Une étude chez des hommes japonais en bonne santé pour tester dans quelle mesure différentes doses de BI 1569912 sont tolérées
Innocuité, tolérabilité et pharmacocinétique de doses orales croissantes uniques et de doses orales multiples de BI 1569912 chez des sujets japonais de sexe masculin en bonne santé (en simple aveugle, partiellement randomisés au sein de groupes de doses, contrôlés par placebo, conception en groupes parallèles)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Tokyo, Sumida-ku, Japon, 130-0004
- SOUSEIKAI Sumida Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Critère d'intégration:
- Sujets masculins en bonne santé selon l'évaluation de l'investigateur, basée sur des antécédents médicaux complets comprenant un examen médical, des signes vitaux (pression artérielle (TA), pouls (PR)), électrocardiogramme à 12 dérivations (ECG) et laboratoire clinique essais
- Ethnicité japonaise, selon les critères suivants : né au Japon, avoir vécu hors du Japon
- Âge de 20 à 45 ans (inclus)
- Indice de masse corporelle (IMC) de 18,5 à 25,0 kg/m2 (inclus)
- Consentement éclairé écrit signé et daté avant l'admission à l'étude, conformément aux bonnes pratiques cliniques (BPC) et à la législation locale
- Sujets qui acceptent de minimiser le risque de rendre leur partenaire enceinte en remplissant l'un des critères suivants à partir de la première administration du médicament d'essai jusqu'à 90 jours après la dernière administration du médicament d'essai
- Utilisation d'une contraception adéquate, l'une des méthodes suivantes plus préservatif : dispositif intra-utérin, contraceptifs oraux combinés commencés au moins 2 mois avant la première administration du médicament.
- Vasectomie (vasectomie au moins 1 an avant l'inscription)
- Stérilisation chirurgicale (y compris occlusion tubaire bilatérale, hystérectomie ou ovariectomie bilatérale) de la partenaire féminine du sujet
Critère d'exclusion:
- Tout résultat de l'examen médical (y compris BP, PR ou ECG) s'écartant de la normale et évalué comme cliniquement pertinent par l'investigateur
- Mesure répétée de la pression artérielle systolique en dehors de la plage de 90 à 140 mmHg, de la pression artérielle diastolique en dehors de la plage de 40 à 90 mmHg ou du pouls en dehors de la plage de 40 à 99 battements par minute (bpm)
- Toute valeur de laboratoire en dehors de la plage de référence que l'investigateur considère comme cliniquement pertinente
- Toute preuve d'une maladie concomitante évaluée comme cliniquement pertinente par l'investigateur
- Affections gastro-intestinales, hépatiques, rénales, respiratoires, cardiovasculaires, métaboliques, immunologiques ou hormonales
- Cholécystectomie ou autre intervention chirurgicale du tractus gastro-intestinal pouvant interférer avec la pharmacocinétique du médicament à l'essai (sauf appendicectomie ou réparation simple d'une hernie)
- Maladies du système nerveux central (y compris, mais sans s'y limiter, tout type de convulsions ou d'accidents vasculaires cérébraux) et autres troubles neurologiques ou psychiatriques pertinents
- Antécédents d'hypotension orthostatique, d'évanouissements ou de pertes de connaissance pertinents D'autres critères d'exclusion s'appliquent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Expérimental: 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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Expérimental: 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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Expérimental: 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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Expérimental: 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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Comparateur placebo: 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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Expérimental: 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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Expérimental: 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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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SRD Part - Number of Subjects With Drug-related Adverse Events
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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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-∞)
Délai: 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-∞)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 1447-0004
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