Vyšetřování bezpečnosti, snášenlivosti a farmakokinetiky (PK) GSK3494245 u zdravých účastníků
8. dubna 2026 aktualizováno: GlaxoSmithKline
Randomizovaná, dvojitě zaslepená, placebem kontrolovaná, první studie na lidech k vyhodnocení bezpečnosti, snášenlivosti a farmakokinetiky jednotlivých dávek (ve stavu nasycení i nalačno) GSK3494245 u zdravých účastníků
Toto je fáze 1, dvojitě zaslepená, randomizovaná, placebem kontrolovaná, první studie na lidech (FTIH) za účelem posouzení bezpečnosti, snášenlivosti a PK jedné dávky GSK3494245.
Studie se bude skládat ze 3 kohort, prováděných postupně.
Skupiny 1 a 2 se budou skládat z jedné vzestupné dávky (SAD), crossover design, kde každý účastník dostane maximálně 3 vzestupné orální dávky GSK3494245 a 1 dávku placeba nalačno.
Při každé hladině dávky budou GSK3494245 a placebo podávány v poměru 3:1, v každém období, podle schématu randomizace zaslepeným způsobem.
Kohorta 3 se bude skládat z 2cestného křížení, které zahrnuje 1 dávkovači režim za podmínek nalačno a poté nalačno a 1 režim za podmínek nalačno a poté nalačno v poměru 1:1.
Podmínky krmení budou zkoumat účinek bezpečnosti, snášenlivosti a PK jedné dávky GSK3494245 po podání potravy.
Přehled studie
Detailní popis
The study originally planned to include 2 parts - a single ascending doses (SAD) part and a multiple ascending doses (MAD) part, incorporating a food effect component to investigate the influence of food on the PK of GSK3494245.
However, only the SAD part was conducted due to a decision to terminate the study early.
Typ studie
Intervenční
Zápis (Aktuální)
59
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Cambridge, Spojené království, CB2 2GG
- GSK Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 50 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Popis
Kritéria pro zařazení
- Účastníkovi musí být v době podpisu informovaného souhlasu 18 až <=50 let.
- Účastník musí být zdravý, jak určí zkoušející nebo lékařsky kvalifikovaná osoba na základě lékařského posouzení včetně anamnézy, fyzikálního vyšetření, laboratorních testů a monitorování srdce. Účastník s klinickou abnormalitou nebo laboratorními parametry, které nejsou konkrétně uvedeny v kritériích pro zařazení nebo vyloučení, mimo normální referenční rozmezí pro studovanou populaci, může být zařazen pouze v případě, že zkoušející po konzultaci s lékařským monitorem ( v případě potřeby) souhlasit a zdokumentovat, že nález pravděpodobně nezavede další rizikové faktory a nebude narušovat postupy studie.
- Tělesná hmotnost >=50 kilogramů (kg) a index tělesné hmotnosti (BMI) v rozmezí 18,5-28 kilogramů na metr čtvereční (kg/m^2) (včetně).
- Pouze mužští účastníci. Mužský účastník s partnerkou s reprodukčním potenciálem musí souhlasit s používáním antikoncepce během intervenčního období a po dobu nejméně 90 dnů po poslední dávce studijní léčby a během tohoto období se zdržet darování spermatu.
- Schopnost poskytnout podepsaný informovaný souhlas, který zahrnuje shodu s požadavky a omezeními uvedenými ve formuláři informovaného souhlasu (ICF) a protokolu.
Kritéria vyloučení
- Anamnéza nebo přítomnost kardiovaskulárních, respiračních, jaterních, ledvinových, gastrointestinálních, endokrinních, hematologických nebo neurologických poruch schopných významně změnit absorpci, metabolismus nebo eliminaci léků; představovat riziko při užívání studijní léčby; nebo zasahování do interpretace dat.
- Abnormální krevní tlak, jak určil vyšetřovatel.
- Předchozí historie leishmaniózy.
- alaninaminotransferáza (ALT) vyšší než 1,5násobek horní hranice normálu (ULN).
- Celkový bilirubin vyšší než 1,5násobek ULN (izolovaný bilirubin vyšší než 1,5násobek ULN je přijatelný, pokud je celkový bilirubin frakcionován a přímý bilirubin nižší než 35 procent [%)].
- Současná nebo chronická anamnéza onemocnění jater nebo známé abnormality jater nebo žlučových cest (s výjimkou Gilbertova syndromu nebo asymptomatických žlučových kamenů).
- Současná nebo anamnéza klinicky významné gastritidy nebo gastroduodenálních vředů nebo pravidelné užívání nesteroidních protizánětlivých léků (NSAID).
- Konzumace více než 14 jednotek/týden alkoholu (muži dobrovolníci).
- Současná nebo anamnéza změny chuti nebo vůně bez jakéhokoli přijatelného klinického vysvětlení na základě klinického úsudku výzkumníka.
- QTc větší než 450 milisekund (ms) na základě průměru trojitého EKG.
- Abnormality tvaru vlny včetně tripletů předčasné ventrikulární kontrakce (PVC) a více než 500 jednotlivých PVC za 24 hodin nebo jakékoli jiné abnormality podle uvážení zkoušejícího.
- Srdeční arytmie nebo srdeční onemocnění nebo rodinná či osobní anamnéza syndromu dlouhého QT intervalu.
- Minulé nebo zamýšlené použití volně prodejných léků nebo léků na předpis, včetně rostlinných léků, NSAID, inhibitorů protonové pumpy (PPI) nebo antagonistů antihistaminového receptoru 2 (H2) během 7 dnů (nebo 14 dnů, pokud je lék potenciálním enzymem induktor) nebo 5 poločasů (podle toho, který je nejdelší) před podáním dávky. Zkoušející po konzultaci s lékařským monitorem může případ od případu zvážit další souběžnou medikaci. Paracetamol je povolen (s omezením na <=2 gramy/den).
- Účast ve studii, která by vedla ke ztrátě krve nebo krevních produktů přesahující 500 mililitrů (ml) během 56denního období.
- Expozice více než 4 novým chemickým látkám během 12 měsíců před prvním dnem dávkování.
- Aktuální registrace nebo účast v minulosti během posledních 30 dnů před podepsáním souhlasu v jakékoli jiné klinické studii zahrnující intervenční studii nebo jakýkoli jiný typ lékařského výzkumu.
- Současný zápis nebo předchozí účast v této klinické studii.
- Účastníci s renální funkcí definovanou jako Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) s věkově vhodnou glomerulární filtrací (GFR) <90 (mililitr za minutu na 1,73 metru čtverečního [ml/min/1,73 m^2]).
- Screening poměru albumin:kreatinin v moči >30 miligramů na gram (mg/g) (>3 miligramy na milimol [mg/mmol])
- Přítomnost výsledku testu povrchového antigenu hepatitidy B (HBsAg) při screeningu.
- Pozitivní výsledek testu na protilátky proti hepatitidě C při screeningu.
- Pozitivní výsledek testu hepatitidy C na ribonukleovou kyselinu (RNA) při screeningu.
- Pozitivní test na protilátky proti viru lidské imunodeficience (HIV).
- Přítomnost klinicky významné hematurie a/nebo proteinurie.
- Hladiny oxidu uhelnatého svědčící o kouření nebo anamnéze nebo pravidelném užívání tabáku nebo výrobků obsahujících nikotin během 3 měsíců před screeningem.
- Pozitivní screening drog/alkoholu před studií.
- Pravidelné užívání známých návykových látek.
- Pouze kohorta 3 s vlivem jídla: Účastník nesmí mít žádná dietní omezení (např. intoleranci laktózy) nebo nesmí mít možnost jíst želatinu nebo upravené standardní jídlo (obsahuje 35–40 % tuku).
- Pouze skupina 3 s vlivem jídla: Anamnéza operace žlučníku nebo odstranění žlučníku nebo anamnéza akutního chorobného stavu (např. cholelitiáza) během 14 dnů před podáním studijní léčby.
- Účastníci nesměli cestovat do oblasti (jak určil zkoušející) s vysokou prevalencí leishmaniálních/parazitárních infekcí během 6 měsíců před screeningem, nebo tak zamýšleli učinit během 3 měsíců po poslední dávce studijní léčby.
- Citlivost na jakoukoli léčbu ve studii nebo její složky nebo alergie na léky nebo jiné alergie, které podle názoru zkoušejícího nebo lékařského monitoru GSK kontraindikují účast ve studii.
- Pozitivní laboratorní potvrzení nákazy koronavirem 2019 (COVID-19) nebo vysoký klinický index podezření na COVID-19.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Cohort 1 Treatment Sequence (Seq) 1: GSK3494245 20 milligram (mg) fasted/Placebo (PBO)
Participants received 20 mg of GSK3494245 during dosing period 1 and Placebo matching the active dose amount during dosing period 2 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
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Experimentální: Cohort 1 Treatment Seq 2: PBO/GSK3494245 40mg fasted
Participants received Placebo during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
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Experimentální: Cohort 1 Treatment Seq 3: GSK3494245 20mg fasted/GSK3494245 40mg fasted
Participants received 20 mg of GSK3494245 during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
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Experimentální: Cohort 1 Treatment Seq 4: GSK3494245 20mg fasted/GSK3494245 40mg fasted
Participants received 20 mg of GSK3494245 during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
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Experimentální: Cohort 2 Treatment Seq 1:GSK3494245 40mg fasted/GSK3494245 80mg fasted/GSK3494245 120mg fasted/PBO
Participants received 40 mg of GSK3494245 during dosing period 1, 80 mg of GSK3494245 during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and matching Placebo during dosing period 4 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 2 Treatment Seq 2:GSK3494245 40mg fasted/GSK3494245 80mg fasted/PBO/GSK3494245 160mg fasted
Participants received 40 mg of GSK3494245 during dosing period 1, 80 mg of GSK3494245 during dosing period 2, matching placebo during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 2 Treatment Seq 3:GSK3494245 40mg fasted/PBO/GSK3494245 120mg fasted/GSK3494245 160mg fasted
Participants received 40 mg of GSK3494245 during dosing period 1, matching placebo during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 2 Treatment Seq 4: PBO/GSK3494245 80mg fasted/GSK3494245 120mg fasted/GSK3494245 160mg fasted
Participants received placebo during dosing period 1, 80 mg of GSK3494245 during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 2A Treatment Seq 1: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
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Experimentální: Cohort 2A Treatment Seq 2: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
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Experimentální: Cohort 2A Treatment Seq 3: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
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Experimentální: Cohort 2A Treatment Seq 4: PBO fasted
Participants received Placebo during dosing period 1 under fasted conditions, at Day 1.
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Matching placebo capsules were provided
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Experimentální: Cohort 3 Treatment Seq 1: PBO fed/PBO fasted/GSK3494245 80mg fasted/GSK3494245 80mg fed
Participants received Placebo in fed conditions during dosing period 1, Placebo in fasted conditions during dosing period 2, 80 mg of GSK3494245 in fasted conditions during dosing period 3 and 80 mg of GSK3494245 in fed conditions during dosing period 4.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 3 Treatment Seq 2: PBO fasted/GSK3494245 80mg fed/PBO fed/GSK3494245 80mg fasted
Participants received Placebo in fasted conditions during dosing period 1, 80 mg of GSK3494245 in fed conditions during dosing period 2, placebo in fed conditions during dosing period 3 and 80 mg of GSK3494245 in fasted conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 3 Treatment Seq 3: GSK3494245 80mg fed/GSK3494245 80mg fasted/PBO fasted/PBO fed
Participants received 80 mg of GSK3494245 in fed conditions during dosing period 1, 80 mg of GSK3494245 in fasted conditions during dosing period 2, Placebo in fasted conditions during dosing period 3 and placebo in fed conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 3 Treatment Seq 4: GSK3494245 80mg fasted/PBO fed/GSK3494245 80mg fed/PBO fasted
Participants received 80 mg of GSK3494245 in fasted conditions during dosing period 1, Placebo in fed conditions during dosing period 2, 80 mg of GSK3494245 in fed conditions during dosing period 3 and placebo in fasted conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 3A Treatment Seq 1: PBO fed/GSK3494245 240mg fed
Participants received placebo in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 3A Treatment Seq 2: GSK3494245 160mg fed/PBO fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and Placebo in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimentální: Cohort 3A Treatment Seq 3: GSK3494245 160mg fed/GSK3494245 240mg fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
|
Experimentální: Cohort 3A Treatment Seq 4: GSK3494245 160mg fed/GSK3494245 240mg fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants With Adverse Events (AEs)
Časové okno: From Day 1 (first dose) up to 14 days post last dose in each treatment period
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
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From Day 1 (first dose) up to 14 days post last dose in each treatment period
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Number of Participants With Serious Adverse Events (SAEs)
Časové okno: From the signing of the informed consent form (a period starting up to 28 days before the first dose on Day 1) to up to 14 days after the last dose of each treatment period
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A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
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From the signing of the informed consent form (a period starting up to 28 days before the first dose on Day 1) to up to 14 days after the last dose of each treatment period
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Number of Participants With Treatment Emergent AEs (TEAEs) and Treatment Emergent SAEs
Časové okno: From Day 1 (first dose) up to 2 days post last dose in each treatment period
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A TEAE and treatment emergent SAE is considered any untoward medical occurrence in a clinical study participant, considered by the investigator to have a causal relationship with study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. |
From Day 1 (first dose) up to 2 days post last dose in each treatment period
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Summary of Change From Baseline in Hematology Parameters: Basophils, Neutrophils, Eosinophils, Lymphocytes, Monocytes and Platelets
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
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Blood samples were collected for the assessment of the hematology parameters: basophils, neutrophils, eosinophils, lymphocytes, monocytes and platelets.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
Standard deviation (SD)=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
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At Day 2 and Day 4 in each treatment period compared to Baseline
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Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Volume
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
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Blood samples were collected for the assessment of the hematology parameters: mean corpuscular volume.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
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At Day 2 and Day 4 in each treatment period compared to Baseline
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Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: mean corpuscular hemoglobin.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
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Summary of Change From Baseline in Hematology Parameters: Erythrocytes and Reticulocytes
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: erythrocytes and reticulocytes.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
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Summary of Change From Baseline in Hematology Parameters: Hemoglobin
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: hemoglobin.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Hematocrit and Reticulocytes
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: hematocrit and reticulocytes.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
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Summary of Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT)
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: ALT, ALP, AST, CPK, and GGT.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Albumin, Protein
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: albumin and protein.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Calcium Corrected for Albumin, Glucose, Lactic Acid, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, and Urea
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for clinical chemistry parameters: bicarbonate, calcium corrected for albumin, glucose, lactic acid, magnesium, phosphate, potassium, sodium, triglycerides, urea.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
Generally, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments on Day 1 lacked timing, the first recorded was used.
If one Day 1 assessment lacked timing, the last available from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, Baseline was set to missing.
Change from baseline is defined as post-dose value minus baseline value.
SD=0.0000 indicates SD below the detectable assay limit, approximated to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: bilirubin, creatinine, direct bilirubin.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: C-reactive Protein (CRP)
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: CRP.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: pH
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: pH.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Number of Participants With Worst-case Urinalysis Results
Časové okno: From Day 1 up to 14 Days post last dose
|
Urine samples were collected for the assessment of urinalysis parameters, which include pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
|
From Day 1 up to 14 Days post last dose
|
|
Summary of Change From Baseline in Physical Examinations: Body Mass Index (BMI)
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Vital Signs: Respiratory Rate
Časové okno: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Vital Signs: Supine Diastolic Blood Pressure, Supine Systolic Blood Pressure
Časové okno: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Vital Signs: Supine Pulse Rate
Časové okno: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Vital Signs: Tympanic Membrane Temperature
Časové okno: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Physical Examinations: Weight
Časové okno: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Electrocardiogram (ECG) Parameters: Heart Rate
Časové okno: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in ECG Parameters: PR Interval, QRS Interval, QT Interval, Corrected QT (QTc) Interval, QT Interval Corrected Using Bazett's Formula, QT Interval Corrected, Using Fridericia's Formula
Časové okno: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically measured the PR interval, QRS interval, QT interval, and QTc interval.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Number of Participants With Abnormal Cardiac Telemetry Findings
Časové okno: Up to 24 hours post first dose on Day 1
|
Telemetry is defined as the continuous monitoring of a participant's heart rate and rhythm from a remote location.
|
Up to 24 hours post first dose on Day 1
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Area Under the Plasma Drug Concentration (AUC) Versus Time Curve (AUC[0-t]) of GSK3494245 Following Single Dose Administration, Under Fasting Conditions
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-t) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to the last measurable concentration.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
AUC (0-t) of GSK3494245 Following Single Dose Administration Under Fed Conditions
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-t) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to the last measurable concentration.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
AUC-time Curve From Time Zero to Extrapolated to Infinity (AUC[0-inf]) of GSK3494245 Following Single Dose Administration Under Fasting Condition
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-inf) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to infinity.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
AUC (0-inf) of GSK3494245 Following Single Dose Administration Under Fed Conditions
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-inf) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to infinity
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Maximum Observed Plasma Drug Concentration (Cmax) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Cmax is defined as the maximum concentration of the drug in plasma.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Cmax of GSK3494245 Following Single Dose Administration Under Fed Conditions
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Cmax is defined as the maximum concentration of the drug in plasma.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Tmax of GSK3494245 Following Single Dose Administration Under Fed Conditions
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Apparent Terminal Half-life (t1/2) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
t1/2 is defined as the time required by the plasma concentration to decline by 50%.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
t1/2 of GSK3494245 Following Single Dose Administration Under Fed Conditions
Časové okno: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
t1/2 is defined as the time required by the plasma concentration to decline by 50%.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Dose-proportionality Assessment Using AUC(0-inf) Following a Single Dose of GSK3494245
Časové okno: At Day 1 (post-dose)
|
A power model was used to assess the dose proportionality.
A slope of 1 indicates that PK increased linearly with the dose.
A slope greater than 1 indicates that PK increased more than proportionally with increase in the dose.
|
At Day 1 (post-dose)
|
|
Dose-proportionality Assessment Using Cmax Following Single Dose of GSK3494245
Časové okno: At Day 1 (post-dose)
|
A power model was used to assess the dose proportionality.
A slope of 1 indicates that PK increased linearly with the dose.
A slope greater than 1 indicates that PK increased more than proportionally with increase in the dose.
|
At Day 1 (post-dose)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: GSK Clinical Trials, GlaxoSmithKline
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
29. září 2020
Primární dokončení (Aktuální)
14. ledna 2024
Dokončení studie (Aktuální)
14. ledna 2024
Termíny zápisu do studia
První předloženo
5. srpna 2020
První předloženo, které splnilo kritéria kontroly kvality
5. srpna 2020
První zveřejněno (Aktuální)
7. srpna 2020
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. dubna 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 208441
- 2019-004492-39 (Číslo EudraCT)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
IPD pro tuto studii bude zpřístupněna prostřednictvím stránky žádosti o data klinické studie.
Časový rámec sdílení IPD
IPD bude zpřístupněna do 6 měsíců od zveřejnění výsledků primárních cílů, klíčových sekundárních cílů a údajů o bezpečnosti studie.
Kritéria přístupu pro sdílení IPD
Přístup je poskytován poté, co je předložen návrh výzkumu a obdržel souhlas od nezávislého kontrolního panelu a poté, co je uzavřena dohoda o sdílení dat.
Přístup je poskytován na počáteční období 12 měsíců, ale v odůvodněných případech lze povolit prodloužení až o dalších 12 měsíců.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .