A GSK3494245 biztonságossági, tolerálhatósági és farmakokinetikai (PK) vizsgálata egészséges résztvevőknél
2026. április 8. frissítette: GlaxoSmithKline
Véletlenszerű, kettős vak, placebo-kontrollos, első alkalommal végzett humán vizsgálat a GSK3494245 egyszeri (ételt és éhezett állapotú) dózisainak biztonságosságának, tolerálhatóságának és farmakokinetikájának értékelésére egészséges résztvevőknél
Ez egy 1. fázisú, kettős-vak, randomizált, placebo-kontrollos, első alkalommal végzett humán (FTIH) vizsgálat a GSK3494245 egyszeri dózisának biztonságosságának, tolerálhatóságának és farmakokinetikai vizsgálatának felmérésére.
A vizsgálat 3 kohorszból áll majd, egymást követő módon.
Az 1. és 2. kohorsz egyetlen növekvő dózisból (SAD) fog állni, keresztezett elrendezésben, ahol minden résztvevő legfeljebb 3 növekvő orális adag GSK3494245-öt és 1 adag placebót kap éhgyomorra.
Mindegyik dózisszinten a GSK3494245-öt és a placebót 3:1 arányban adják be minden perióduson belül, a randomizációs ütemterv szerint, vak módon.
A 3. kohorsz egy kétirányú keresztezésből áll, amely 1 adagolási rendet foglal magában éhgyomorra, majd evett körülmények között és 1 adagolási rendet étkezés után éheztetett körülmények között 1:1 arányban.
Az etetési körülmények megvizsgálják a GSK3494245 egyszeri adagjának biztonságosságát, tolerálhatóságát és farmakokinetikai hatását az élelmiszer beadását követően.
A tanulmány áttekintése
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
59
Fázis
- 1. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
-
-
Cambridge, Egyesült Királyság, CB2 2GG
- GSK Investigational Site
-
-
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt)
Egészséges önkénteseket fogad
Igen
Leírás
Befogadási kritériumok
- A résztvevőnek 18 és <=50 év közötti életkorúnak kell lennie a tájékozott hozzájárulás aláírásának időpontjában.
- A résztvevőnek egészségesnek kell lennie, ahogy azt a Vizsgáló vagy az orvosi képesítéssel rendelkező megbízott orvosi értékelés alapján megállapította, beleértve a kórelőzményt, a fizikális vizsgálatot, a laboratóriumi vizsgálatokat és a szívellenőrzést. Az a résztvevő, akinek olyan klinikai eltérése vagy laboratóriumi paraméterei vannak, amelyek nem szerepel(nek) kifejezetten a felvételi vagy kizárási kritériumok között, a vizsgált populáció normál referenciatartományán kívül, csak akkor vehetők fel, ha a vizsgáló az orvosi monitorral egyeztetve ( ha szükséges) elfogadja és dokumentálja, hogy a megállapítás nem valószínű, hogy további kockázati tényezőket vezet be, és nem zavarja a vizsgálati eljárásokat.
- Testtömeg >=50 kilogramm (kg) és testtömeg-index (BMI) a 18,5-28 kilogramm négyzetméterenként (kg/m^2) (beleértve).
- Csak férfi résztvevők. A reproduktív potenciállal rendelkező női partnerrel rendelkező férfi résztvevőnek bele kell egyeznie abba, hogy fogamzásgátlást alkalmaz a beavatkozási időszak alatt és legalább 90 napig a vizsgálati kezelés utolsó adagja után, és tartózkodnia kell a sperma adományozásától ebben az időszakban.
- Képes aláírt beleegyező nyilatkozat megadására, amely magában foglalja a Tájékozott hozzájárulási űrlapon (ICF) és a protokollban felsorolt követelmények és korlátozások betartását.
Kizárási kritériumok
- Olyan szív- és érrendszeri, légzőszervi, máj-, vese-, gasztrointesztinális, endokrin, hematológiai vagy neurológiai rendellenességek kórtörténete vagy jelenléte, amelyek képesek jelentősen megváltoztatni a gyógyszerek felszívódását, metabolizmusát vagy eliminációját; kockázatot jelent a vizsgálati kezelés során; illetve az adatok értelmezésében való beavatkozás.
- A vizsgáló által megállapított kóros vérnyomás.
- A leishmaniasis korábbi története.
- Az alanin-aminotranszferáz (ALT) értéke meghaladja a normál felső határának (ULN) 1,5-szeresét.
- Az összbilirubin a normálérték felső határának 1,5-szörösénél nagyobb (az izolált bilirubin 1,5-szörösénél nagyobb, ha az összbilirubin frakcionált, a direkt bilirubin pedig kevesebb, mint 35 százalék [%).
- Jelenlegi vagy krónikus májbetegség, vagy ismert máj- vagy eperendszeri rendellenességek (a Gilbert-szindróma vagy a tünetmentes epekő kivételével).
- Klinikailag jelentős gyomorhurut vagy gyomor-nyombélfekély fennállása vagy a kórtörténetben, vagy nem szteroid gyulladáscsökkentő szerek (NSAID) rendszeres alkalmazása.
- Heti 14 egységnél nagyobb alkoholfogyasztás (önkéntes férfiak).
- Az íz- vagy szagváltozás jelenlegi vagy anamnézisében a vizsgáló klinikai megítélése alapján bármilyen elfogadható klinikai magyarázat nélkül.
- QTc több mint 450 milliszekundum (msec), a három ismétlődő EKG átlaga alapján.
- Hullámforma-rendellenességek, beleértve a korai kamrai kontrakció (PVC) tripleteket és több mint 500 egyedi PVC-t 24 órán belül, vagy bármely más rendellenesség a vizsgáló belátása szerint.
- Szívritmuszavar vagy szívbetegség anamnézisében, vagy hosszú QT-szindróma családi vagy személyes anamnézisében.
- Vény nélkül kapható vagy vényköteles gyógyszerek, beleértve a növényi eredetű gyógyszereket, NSAID-okat, protonpumpa-gátlókat (PPI) vagy antihisztamin 2 receptor (H2) antagonistákat, múltbeli vagy tervezett használata 7 napon belül (vagy 14 napon belül, ha a gyógyszer potenciális enzim induktor) vagy 5 felezési idő (amelyik a leghosszabb) az adagolás előtt. A vizsgáló az orvosi monitorral egyeztetve eseti alapon mérlegelhet egyéb egyidejű gyógyszeres kezelést is. A paracetamol megengedett (legfeljebb 2 gramm/nap).
- Részvétel abban a vizsgálatban, amely 56 napos időszakon belül 500 ml-t meghaladó vér- vagy vérkészítmény-veszteséget eredményez.
- Több mint 4 új kémiai entitásnak való kitettség az első adagolási napot megelőző 12 hónapon belül.
- Jelenlegi beiratkozás vagy korábbi részvétel a hozzájárulás aláírása előtti utolsó 30 napon belül bármely más klinikai vizsgálatban, amely vizsgálati vizsgálati beavatkozást vagy bármilyen más típusú orvosi kutatást foglal magában.
- Jelenlegi beiratkozás vagy korábbi részvétel ebben a klinikai vizsgálatban.
- Krónikus vesebetegség epidemiológiai együttműködésként (CKD-EPI) definiált vesefunkciójú résztvevők, akiknek életkorának megfelelő glomeruláris filtrációs rátája (GFR) <90 (milliliter percenként 1,73 négyzetméteren [ml/perc/1,73 m^2]).
- Szűrő vizelet albumin:kreatinin arány >30 milligramm/gramm (mg/g) (>3 milligramm per millimol [mg/mmol])
- Hepatitis B felszíni antigén (HBsAg) teszt eredménye a szűréskor.
- Pozitív hepatitis C ellenanyag-teszt eredménye a szűréskor.
- Pozitív hepatitis C ribonukleinsav (RNS) teszt eredménye a szűréskor.
- Pozitív humán immundeficiencia vírus (HIV) antitest teszt.
- Klinikailag jelentős hematuria és/vagy proteinuria jelenléte.
- A szűrést megelőző 3 hónapon belül dohányzásra vagy dohányzásra vagy nikotintartalmú termékek rendszeres fogyasztására utaló szén-monoxid-szint.
- Pozitív vizsgálat előtti drog/alkohol szűrés.
- Az ismert kábítószerek rendszeres használata.
- Csak a táplálékhatás 3. kohorsza: A résztvevőnek nem lehet étkezési korlátozása (pl. laktóz intolerancia) vagy képtelen enni zselatint vagy adaptált standard étkezést (35-40% zsírtartalommal).
- Csak a 3. kohorsz táplálékhatása: epehólyagműtét vagy epehólyag-eltávolítás a kórtörténetében, vagy akut betegség a kórtörténetében (pl. cholelithiasis) a vizsgálati kezelés megkezdése előtt 14 napon belül.
- A résztvevők nem utazhattak olyan területre (a vizsgáló meghatározása szerint), ahol magas a leishmaniális/parazita fertőzések előfordulása a szűrést megelőző 6 hónapban, vagy nem szándékoznak utazni a vizsgálati kezelés utolsó adagját követő 3 hónapban.
- Bármely vizsgálati kezeléssel vagy annak összetevőivel szembeni érzékenység, vagy gyógyszer vagy egyéb allergia, amely a Vizsgáló vagy a GSK Medical Monitor véleménye szerint ellenjavallt a vizsgálatban való részvételnek.
- Pozitív laboratóriumi igazolás a 2019-es koronavírus-betegség (COVID-19) fertőzésről, vagy magas a COVID-19 gyanújának klinikai indexe.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Szekvenciális hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Kísérleti: 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
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
|
Kísérleti: 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
|
|
Kísérleti: 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.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Kísérleti: 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
|
|
Kísérleti: 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.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Kísérleti: Cohort 2A Treatment Seq 1: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: Cohort 2A Treatment Seq 3: 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.
|
|
Kísérleti: Cohort 2A Treatment Seq 4: PBO fasted
Participants received Placebo during dosing period 1 under fasted conditions, at Day 1.
|
Matching placebo capsules were provided
|
|
Kísérleti: 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.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Kísérleti: 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
|
|
Kísérleti: 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
|
|
Kísérleti: 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
|
|
Kísérleti: 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
|
|
Kísérleti: 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
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Időkeret: From Day 1 (first dose) up to 14 days post last dose in each treatment period
|
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.
|
From Day 1 (first dose) up to 14 days post last dose in each treatment period
|
|
Number of Participants With Serious Adverse Events (SAEs)
Időkeret: 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
|
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 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
|
|
Number of Participants With Treatment Emergent AEs (TEAEs) and Treatment Emergent SAEs
Időkeret: From Day 1 (first dose) up to 2 days post last dose in each treatment period
|
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
|
|
Summary of Change From Baseline in Hematology Parameters: Basophils, Neutrophils, Eosinophils, Lymphocytes, Monocytes and Platelets
Időkeret: At Day 2 and Day 4 in each treatment period compared to Baseline
|
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.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Volume
Időkeret: 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 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.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin
Időkeret: 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
|
|
Summary of Change From Baseline in Hematology Parameters: Erythrocytes and Reticulocytes
Időkeret: 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
|
|
Summary of Change From Baseline in Hematology Parameters: Hemoglobin
Időkeret: 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
Időkeret: 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
|
|
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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Area Under the Plasma Drug Concentration (AUC) Versus Time Curve (AUC[0-t]) of GSK3494245 Following Single Dose Administration, Under Fasting Conditions
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Tanulmányi igazgató: GSK Clinical Trials, GlaxoSmithKline
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2020. szeptember 29.
Elsődleges befejezés (Tényleges)
2024. január 14.
A tanulmány befejezése (Tényleges)
2024. január 14.
Tanulmányi regisztráció dátumai
Először benyújtva
2020. augusztus 5.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2020. augusztus 5.
Első közzététel (Tényleges)
2020. augusztus 7.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. május 1.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. április 8.
Utolsó ellenőrzés
2026. április 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 208441
- 2019-004492-39 (EudraCT szám)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
Ehhez a vizsgálathoz az IPD a Clinical Study Data Request oldalon lesz elérhető.
IPD megosztási időkeret
Az IPD-t a vizsgálat elsődleges végpontjainak, kulcsfontosságú másodlagos végpontjainak és biztonságossági adatainak közzétételétől számított 6 hónapon belül teszik elérhetővé.
IPD-megosztási hozzáférési feltételek
A hozzáférést a kutatási javaslat benyújtása és a Független Ellenőrző Panel jóváhagyása, valamint az adatmegosztási megállapodás megkötése után biztosítják.
A hozzáférést kezdeti 12 hónapos időtartamra biztosítják, de indokolt esetben további 12 hónapra meghosszabbítható.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
- CSR
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .