En undersøgelse i raske mænd og kvinder for at teste, om BI 1569912 påvirker mængden af repaglinid, midazolam og bupropion i blodet
Effekten af multiple doser af BI 1569912 på enkeltdosis-farmakokinetikken af repaglinid, midazolam og bupropion efter oral administration i raske mandlige og kvindelige forsøgspersoner (et åbent, 2-perioders forsøg med fast sekvens)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Edegem, Belgien, 2650
- SGS Life Science Services - Clinical Research
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Sunde mandlige eller kvindelige forsøgspersoner i henhold til efterforskerens vurdering, baseret på en komplet sygehistorie inklusive en fysisk undersøgelse, standardiseret mental og neurologisk vurdering, vitale tegn (blodtryk (BP), puls (PR)), 12-afledninger Elektrokardiogram (EKG) og kliniske laboratorietest uden klinisk signifikante abnormiteter
- Alder fra 18 til 55 år (inklusive)
- Kropsmasseindeks (BMI) på 18,5 til 29,9 kg/m2 (inklusive)
- Underskrevet og dateret skriftligt informeret samtykke i overensstemmelse med International Council for Harmonisation-Good Clinical Practice (ICH-GCP) og lokal lovgivning forud for optagelse i forsøget
Enten mandlige forsøgspersoner eller kvindelige forsøgspersoner, der opfylder følgende kriterier, der kræver højeffektiv prævention fra mindst 30 dage før den første administration af forsøgsmedicin til 30 dage efter forsøgets afslutning:
- Brug af passende prævention, dvs. brug af kondom (mandlige forsøgspersoner eller mandlige partnere til kvindelige forsøgspersoner) plus en hvilken som helst af følgende metoder (kvindelige forsøgspersoner eller kvindelige partnere til mandlige forsøgspersoner): intrauterin enhed, hormonel prævention (f.eks. implantater, injicerbare præparater, kombinerede orale eller vaginale præventionsmidler), kirurgisk steriliseret (herunder bilateral tubal okklusion/ligation, hysterektomi, bilateral ooforektomi) eller postmenopausal, defineret som ingen menstruation i 1 år uden en alternativ medicinsk årsag (i tvivlsomme tilfælde en blodprøve med niveauer af follikelstimulerende hormon (FSH) over 40 U/L er bekræftende)
- Seksuelt afholdende (betragtes kun som en yderst effektiv metode, hvis den defineres som at afstå fra heteroseksuelt samleje i hele risikoperioden forbundet med undersøgelsesbehandlingerne)
- Vasektomerede mandlige forsøgspersoner eller mandlige partnere til kvindelige forsøgspersoner (vasektomi mindst 1 år før tilmelding) i kombination med en barrieremetode (dvs. brug af kondom) og forudsat at partneren er forsøgsdeltagerens eneste seksuelle partner Ubeskyttet samleje (dvs. uden brug af kondom) af en mandlig forsøgsperson med en gravid kvindelig partner og sæddonation er ikke tilladt under hele undersøgelsen og indtil 30 dage efter forsøgets afslutning. Kvindelige forsøgspersoner bør ikke deltage i ægdonation fra den første forsøgsmedicinindgivelse, i hele undersøgelsens varighed og i mindst 30 dage efter forsøgets afslutning.
Ekskluderingskriterier:
- 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, især leverparametre (alaninaminotransferase (ALT), aspartataminotransferase (AST), total bilirubin) eller nyreparametre (kreatinin), der overstiger den øvre normalgrænse ( ULN) efter gentagne målinger
- 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, bulimi eller anoreksi eller bipolar stemningslidelse) 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: N/A
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Reference treatment (R), then test treatment (T)
Reference Treatment (R): On the morning of Day (D) 1, healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally. On the morning of D2, participants took a single dose of 2 mg of midazolam solution for injection orally. On the morning of D3, participants received orally a single extended-release tablet of 150 mg of bupropion. All medications were administered after an overnight fast of at least 10 hours. Test Treatment (T): Healthy participants received in the morning, for 21 days (D-14 to D7), the intended BI 1569912 daily dose. On the morning of D1, participants took after the administration of BI 1569912, a single tablet of 0.5 mg of repaglinide orally. On the morning of D2, participants took, after the administration of BI 1569912, a single dose of 2 mg of midazolam solution for injection orally. On the morning of D3, participants received orally a single extended-release tablet of 150 mg of bupropion after BI 1569912. No washout period occurred. |
Intended dose of BI 1569912
0.5 mg tablet
2 mg solution for injection
150 mg extended-release tablet
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Tidsramme: Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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Area Under Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Tidsramme: Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Tidsramme: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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This outcome measured the area under the concentration-time curve of chiral form S-bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Tidsramme: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Tidsramme: Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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Maximum Measured Concentration of Repaglinide in Plasma (Cmax)
Tidsramme: Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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This outcome measured maximum measured concentration of repaglinide in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Tidsramme: Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone or co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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Maximum Measured Concentration of Midazolam in Plasma (Cmax)
Tidsramme: Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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This outcome measured maximum measured concentration of midazolam in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
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Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Tidsramme: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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This outcome measured the area under the concentration-time curve of the chiral form S-bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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Maximum Measured Concentration of S-bupropion in Plasma (Cmax)
Tidsramme: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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This outcome measured maximum measured concentration of the chiral form S-bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Tidsramme: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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Maximum Measured Concentration of Total Bupropion in Plasma (Cmax)
Tidsramme: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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This outcome measured maximum measured concentration of total bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed. |
Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.
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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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1447-0007
- 2023-510461-10-00 (Registry Identifier: CTIS)
- U1111-1303-9187 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))
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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