En studie i friske japanske menn for å teste hvor godt ulike doser av BI 1569912 tolereres
Sikkerhet, tolerabilitet og farmakokinetikk for enkeltstående orale doser og flere orale doser av BI 1569912 hos friske mannlige japanske personer (enkeltblinde, delvis randomisert innenfor dosegrupper, placebokontrollert, parallellgruppedesign)
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Tokyo, Sumida-ku, Japan, 130-0004
- SOUSEIKAI Sumida Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- Friske mannlige forsøkspersoner i henhold til vurderingen av etterforskeren, basert på en fullstendig sykehistorie inkludert en medisinsk undersøkelse, vitale tegn (blodtrykk (BP), pulsfrekvens (PR)), 12-avlednings elektrokardiogram (EKG) og klinisk laboratorium tester
- Japansk etnisitet, i henhold til følgende kriterier: født i Japan, har bodd utenfor Japan
- Alder 20 til 45 år (inkludert)
- Kroppsmasseindeks (BMI) på 18,5 til 25,0 kg/m2 (inkludert)
- Signert og datert skriftlig informert samtykke før opptak til studien, i samsvar med Good Clinical Practice (GCP) og lokal lovgivning
Forsøkspersoner som samtykker i å minimere risikoen for å gjøre partneren sin gravid ved å oppfylle noen av følgende kriterier fra første administrasjon av prøvemedisin til 90 dager etter siste administrasjon av prøvemedisin
- Bruk av adekvat prevensjon, en av følgende metoder pluss kondom: intrauterin enhet, kombinerte orale prevensjonsmidler som startet minst 2 måneder før første legemiddeladministrering.
- Vasektomisert (vasektomi minst 1 år før påmelding)
- Kirurgisk sterilisering (inkludert bilateral tubal okklusjon, hysterektomi eller bilateral ooforektomi) av forsøkspersonens kvinnelige partner
Ekskluderingskriterier:
- Ethvert funn i den medisinske undersøkelsen (inkludert BP, PR eller EKG) som avviker fra det normale og vurderes som klinisk relevant av utrederen
- Gjentatte målinger av systolisk blodtrykk utenfor området 90 til 140 mmHg, diastolisk blodtrykk utenfor området 40 til 90 mmHg, eller pulsfrekvens utenfor området 40 til 99 slag per minutt (bpm)
- Enhver laboratorieverdi utenfor referanseområdet som etterforskeren anser for å være av klinisk relevans
- Eventuelle bevis på en samtidig sykdom vurdert som klinisk relevant av etterforskeren
- Gastrointestinale, lever-, nyre-, respiratoriske, kardiovaskulære, metabolske, immunologiske eller hormonelle lidelser
- Kolecystektomi eller annen kirurgi i mage-tarmkanalen som kan forstyrre farmakokinetikken til prøvemedisinen (unntatt blindtarmsoperasjon eller enkel brokkreparasjon)
- Sykdommer i sentralnervesystemet (inkludert men ikke begrenset til noen form for anfall eller slag), og andre relevante nevrologiske eller psykiatriske lidelser
- Anamnese med relevant ortostatisk hypotensjon, besvimelsesanfall eller blackout Ytterligere eksklusjonskriterier gjelder.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Single-rising dose part - BI 1569912 2.5 mg
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
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BI 1569912
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Eksperimentell: Single-rising dose part - BI 1569912 5 mg
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
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BI 1569912
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Eksperimentell: Single-rising dose part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
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BI 1569912
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Eksperimentell: Single-rising dose part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
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BI 1569912
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Eksperimentell: Multiple dose part - 20 mg BI 1569912
Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
The treatment was administered for 14 days.
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BI 1569912
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Placebo komparator: Multiple dose part - Placebo
Healthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours.
The treatment was administered for 14 days.
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Placebo
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Eksperimentell: Evening pharmacokinetics part I - 5 mg BI 1569912 T-R
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h. |
BI 1569912
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Eksperimentell: Evening pharmacokinetics part II - 5 mg BI 1569912 R-T
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h. |
BI 1569912
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Placebo komparator: Single-rising dose part - Placebo
Subjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of. Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours. |
Placebo
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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SRD Part - Number of Subjects With Drug-related Adverse Events
Tidsramme: From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.
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Number of subjects in the single-rising dose (SRD) part with drug-related adverse events (AEs) is reported.
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From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.
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MD Part - Number of Subjects With Drug-related Adverse Events
Tidsramme: From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days.
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Number of subjects in the multiple dose (MD) part with drug-related adverse events is reported.
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From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days.
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Evening PK Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Tidsramme: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
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Evening pharmacokinetics (PK) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale. |
Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
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Evening PK Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Tidsramme: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
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Evening pharmacokinetics (PK) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale. |
Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Evening PK Part - Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Tidsramme: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
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Evening pharmacokinetics (PK) part - area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale. |
Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
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SRD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Tidsramme: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.
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Single-rising dose (SRD) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
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Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.
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SRD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Tidsramme: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.
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Single-rising dose (SRD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported.
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Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.
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MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma From 0 to 24 h (AUC0-24) After the First Dose
Tidsramme: Within 3 h prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.
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Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma from 0 to 24 hours (h) (AUC0-24) after the first dose is reported.
AUC0-24 was calculated by extrapolation
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Within 3 h prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.
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MD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) After the First Dose
Tidsramme: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.
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Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) after the first dose is reported.
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Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.
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MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Dosing Interval τ at Steady State (AUCτ,ss) After the Last Dose
Tidsramme: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.
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Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma over the dosing interval τ at steady state (AUCτ,ss) after the last dose is reported.
The dosing interval τ is 24 hours (h).
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One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.
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MD Part - Maximum Measured Concentration of BI 1569912 in Plasma at Steady State (Cmax,ss) After the Last Dose
Tidsramme: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.
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Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma at steady state (Cmax,ss) after the last dose is reported.
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One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.
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Evening PK Part - Number of Subjects With Drug-related Adverse Events
Tidsramme: From drug administration plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.
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Number of subjects in the evening pharmacokinetics (PK) part with drug-related adverse events is reported.
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From drug administration plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.
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Andre studie-ID-numre
- 1447-0004
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- studier utført i et enkelt senter eller rettet mot sjeldne sykdommer (på grunn av begrensninger med anonymisering).
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