A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects
21 octobre 2015 mis à jour par: Galapagos NV
A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects
This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).
Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated.
A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
24
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Antwerp, Belgique
- SGS LSS Clinical Pharmacology Unit Antwerp
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 50 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- healthy male, age 18-50 years
- BMI between 18-30 kg/m2
Exclusion Criteria:
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Midazolam and 500 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.
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Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
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Expérimental: Midazolam and 1000 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.
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Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Délai: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Délai: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837
Délai: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Délai: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Délai: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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Number of adverse events
Délai: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of the number of adverse events reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature
Délai: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in 12-lead ECG measures
Délai: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in 12-ECG measures reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in physical exam measures
Délai: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in physical examination reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in blood safety lab parameters
Délai: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in blood safety lab parameters reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in urine safety lab parameters
Délai: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in urine safety lab parameters reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Délai: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Délai: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Délai: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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The metabolite to GLPG1837 ratios in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Délai: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the metabolite to GLPG1837 ratios in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2015
Achèvement primaire (Réel)
1 octobre 2015
Achèvement de l'étude (Réel)
1 octobre 2015
Dates d'inscription aux études
Première soumission
23 septembre 2015
Première soumission répondant aux critères de contrôle qualité
27 septembre 2015
Première publication (Estimation)
29 septembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
23 octobre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 octobre 2015
Dernière vérification
1 octobre 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Anesthésiques intraveineux
- Anesthésiques, général
- Anesthésiques
- Agents tranquillisants
- Médicaments psychotropes
- Hypnotiques et sédatifs
- Adjuvants, Anesthésie
- Agents anti-anxiété
- Modulateurs GABA
- Agents GABA
- Midazolam
Autres numéros d'identification d'étude
- GLPG1837-CL-102
- 2015-002517-29 (Numéro EudraCT)
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