Eine Studie an gesunden japanischen Männern, um zu testen, wie gut unterschiedliche Dosen von BI 1569912 vertragen werden
Sicherheit, Verträglichkeit und Pharmakokinetik von ansteigenden oralen Einzeldosen und mehreren oralen Dosen von BI 1569912 bei gesunden männlichen japanischen Probanden (einzeln verblindet, teilweise randomisiert innerhalb von Dosisgruppen, Placebo-kontrolliert, Parallelgruppen-Design)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Tokyo, Sumida-ku, Japan, 130-0004
- SOUSEIKAI Sumida Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- Gesunde männliche Probanden nach Einschätzung des Prüfarztes, basierend auf einer vollständigen Krankengeschichte einschließlich einer medizinischen Untersuchung, Vitalzeichen (Blutdruck (BP), Pulsfrequenz (PR)), 12-Kanal-Elektrokardiogramm (EKG) und klinischem Labor Prüfungen
- Japanische Ethnizität gemäß den folgenden Kriterien: in Japan geboren, außerhalb Japans gelebt
- Alter von 20 bis 45 Jahren (einschließlich)
- Body-Mass-Index (BMI) von 18,5 bis 25,0 kg/m2 (inklusive)
- Unterschriebene und datierte schriftliche Einverständniserklärung vor der Zulassung zur Studie gemäß guter klinischer Praxis (GCP) und lokaler Gesetzgebung
Probanden, die sich bereit erklären, das Risiko einer Schwangerschaft ihrer Partnerin zu minimieren, indem sie eines der folgenden Kriterien ab der ersten Verabreichung der Studienmedikation bis 90 Tage nach der letzten Verabreichung der Studienmedikation erfüllen
- Anwendung einer angemessenen Empfängnisverhütung, eine der folgenden Methoden plus Kondom: Intrauterinpessar, kombinierte orale Kontrazeptiva, die mindestens 2 Monate vor der ersten Arzneimittelverabreichung begonnen wurde.
- Vasektomie (Vasektomie mindestens 1 Jahr vor Einschreibung)
- Chirurgische Sterilisation (einschließlich bilateraler Tubenverschluss, Hysterektomie oder bilateraler Ovarektomie) der Partnerin des Subjekts
Ausschlusskriterien:
- Jeder Befund bei der medizinischen Untersuchung (einschließlich BP, PR oder EKG), der vom Normalwert abweicht und vom Prüfarzt als klinisch relevant bewertet wird
- Wiederholte Messung des systolischen Blutdrucks außerhalb des Bereichs von 90 bis 140 mmHg, des diastolischen Blutdrucks außerhalb des Bereichs von 40 bis 90 mmHg oder der Pulsfrequenz außerhalb des Bereichs von 40 bis 99 Schlägen pro Minute (bpm)
- Jeder Laborwert außerhalb des Referenzbereichs, den der Prüfarzt für klinisch relevant hält
- Jeder Hinweis auf eine Begleiterkrankung, die vom Prüfarzt als klinisch relevant bewertet wird
- Gastrointestinale, hepatische, renale, respiratorische, kardiovaskuläre, metabolische, immunologische oder hormonelle Störungen
- Cholezystektomie oder andere Operation des Gastrointestinaltrakts, die die Pharmakokinetik der Studienmedikation beeinträchtigen könnte (außer Appendektomie oder einfache Hernienreparatur)
- Erkrankungen des Zentralnervensystems (einschließlich, aber nicht beschränkt auf alle Arten von Krampfanfällen oder Schlaganfällen) und andere relevante neurologische oder psychiatrische Erkrankungen
- Anamnestisch relevante orthostatische Hypotonie, Ohnmachtsanfälle oder Blackouts. Es gelten weitere Ausschlusskriterien.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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SRD Part - Number of Subjects With Drug-related Adverse Events
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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-∞)
Zeitfenster: 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-∞)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 1447-0004
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