En undersøgelse i raske mænd for at teste, hvordan forskellige doser af BI 3000202 tolereres, og hvordan mad påvirker mængden af BI 3000202 i blodet
Et randomiseret, enkelt-blindt, placebo-kontrolleret forsøg til undersøgelse af sikkerhed, tolerabilitet og farmakokinetik af enkelte stigende doser af BI 3000202 administreret som tablet til raske mandlige forsøgspersoner og en randomiseret, åben-label, enkeltdosis, to-vejs krydsning -over relativ biotilgængelighed sammenligning af BI 3000202 som tablet med og uden mad i sunde mandlige forsøgspersoner
Den enkelte stigende dosis (SRD) del af forsøget undersøger sikkerhed, tolerabilitet og farmakokinetik af BI 3000202.
Food effect (FE) delen udføres for at vurdere effekten af fødevarer på den relative biotilgængelighed af BI 3000202 formuleringen.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Biberach, Tyskland, 88397
- Humanpharmakologisches Zentrum Biberach
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier
- Sunde mandlige forsøgspersoner i henhold til investigatorens vurdering, baseret på en komplet sygehistorie inklusive en fysisk undersøgelse, vitale tegn (blodtryk (BP), pulsfrekvens (PR)), 12-aflednings elektrokardiogram (EKG) og klinisk laboratorium test uden nogen klinisk signifikante abnormiteter
- Alder fra 18 til 45 år (inklusive)
- Kropsmasseindeks (BMI) på 18,5 til 29,9 kg/m^2 (inklusive)
- Underskrevet og dateret skriftligt informeret samtykke i overensstemmelse med ICH-GCP og lokal lovgivning forud for optagelse i forsøget
Eksklusionskriterier
- Ethvert fund i lægeundersøgelsen (inklusive BP, PR eller EKG), der afviger fra det normale og vurderet som klinisk relevant af investigator
- Gentagen måling af systolisk blodtryk uden for området 90 til 140 millimeter kviksølv (mmHg), diastolisk blodtryk uden for området 50 til 90 mmHg eller puls uden for området 50 til 90 slag i minuttet (bpm)
- Enhver laboratorieværdi uden for referenceområdet, som investigator anser for at være af klinisk relevans
- Ethvert bevis på en samtidig sygdom vurderet som klinisk relevant af investigator
- Gastrointestinale, lever-, nyre-, respiratoriske, kardiovaskulære, metaboliske, immunologiske eller hormonelle lidelser
- Kolecystektomi eller anden operation i mave-tarmkanalen, der kan forstyrre farmakokinetikken af forsøgsmedicinen (undtagen blindtarmsoperation eller simpel brokreparation)
- Sygdomme i centralnervesystemet (herunder men ikke begrænset til enhver form for anfald eller slagtilfælde) og andre relevante neurologiske eller psykiatriske lidelser
- Anamnese med relevant ortostatisk hypotension, besvimelsesanfald eller blackouts Yderligere eksklusionskriterier gælder.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Single rising dose (SRD): Placebo matching BI 3000202
SRD part: A single administration of 1 film-coated tablet identical to the active BI 3000202 treatment was orally given with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
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BI 3000202
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Eksperimentel: SRD: Dose 1 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
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BI 3000202
Placebo matchende BI 3000202
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Eksperimentel: SRD: Dose 2 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
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BI 3000202
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Eksperimentel: SRD: Dose 3 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
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BI 3000202
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Eksperimentel: SRD: Dose 4 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
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BI 3000202
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Eksperimentel: SRD: Dose 5 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
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BI 3000202
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Eksperimentel: SRD: Dose 6 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
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BI 3000202
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Eksperimentel: SRD: Dose 7 - BI 3000202
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
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BI 3000202
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Eksperimentel: Food effect (FE): Low dose III BI 3000202 fasted (R) / fed (T)
FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). There was a minimum 3-day washout period between the two treatments. |
BI 3000202
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Eksperimentel: FE: Low dose III BI 3000202 fed (T) / fasted (R)
FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R). There was a minimum 3-day washout period between the two treatments. |
BI 3000202
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
Tidsramme: From drug administration on Day 1 plus REP of 48 hours, up to 2 days.
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Number of any treatment-emergent adverse event assessed as drug-related by the investigator. Percentages were calculated using the total number of participants per treatment as denominator. MedDRA version 26.1 was used for reporting. All adverse events occurring up to 48 hours (2 days) after drug administration were assigned to treatment. Medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history. |
From drug administration on Day 1 plus REP of 48 hours, up to 2 days.
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FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Tidsramme: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24). The AUC0-24 endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and fixed effects 'sequence' 'period' and 'treatment'. |
Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Tidsramme: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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Maximum measured concentration of BI 3000202 in plasma (Cmax). The Cmax endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'. |
Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Tidsramme: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24) was analyzed descriptively.
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Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Tidsramme: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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Maximum measured concentration of BI 3000202 in plasma was analyzed descriptively.
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Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞)
Tidsramme: Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to infinity (AUC0-∞). The AUC0-∞ endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'. |
Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1509-0001
- 2022-502424-43-00 (Registry Identifier: CTIS)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Kliniske undersøgelser sponsoreret af Boehringer Ingelheim, fase I til IV, interventionelle og ikke-interventionelle, er mulighed for deling af de rå kliniske undersøgelsesdata og kliniske undersøgelsesdokumenter. Der kan være undtagelser, f.eks. undersøgelser af produkter, hvor Boehringer Ingelheim ikke er licensindehaver; undersøgelser vedrørende farmaceutiske formuleringer og tilknyttede analysemetoder og undersøgelser, der er relevante for farmakokinetik ved brug af humane biomaterialer; undersøgelser udført i et enkelt center eller rettet mod sjældne sygdomme (i tilfælde af lavt antal patienter og derfor begrænsninger med anonymisering).
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