Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food
21 octobre 2015 mis à jour par: Galapagos NV
An Open-label Study to Compare the Oral Bioavailability of an Oral Tablet of GLPG1837 Relative to an Oral Suspension After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Oral Tablet
The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, in male healthy subjects.
Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, will be assessed.
Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be separated by a wash-out period of at least 6 days.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
12
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 croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: GLPG1837 as oral suspension fasted
Single dose of 500 mg GLPG1837 as oral suspension after an overnight fast
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A single dose of 500 mg GLPG1837 administered as oral suspension
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Expérimental: GLPG1837 as oral tablet fasted
Single dose of 500 mg GLPG1837 as oral tablet after an overnight fast
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A single dose of 500 mg GLPG1837 administered as oral tablet
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Expérimental: GLPG1837 as oral tablet fed
Single dose of 500 mg GLPG1837 as oral tablet after a high-fat high-calorie breakfast
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A single dose of 500 mg GLPG1837 administered as oral tablet
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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 GLPG1837 (metabolite) in plasma
Délai: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma
Délai: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)
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The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma
Délai: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma
Délai: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the area under the plasma concentration versus time curve of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma
Délai: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the apparent terminal half-life of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The metabolite over GLPG1837 ratios in plasma
Délai: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the metabolite over GLPG1837 ratios in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of adverse events
Délai: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of number of adverse events (AEs) reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in vital signs as measured by heart rate, blood pressure and oral body temperature
Délai: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in vital signs as measured by heart rate, blood pressure and oral body temperature reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in 12-lead ECG measures
Délai: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in 12-ECG measures reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in physical exam measures
Délai: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in physical examination reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in blood safety lab parameters
Délai: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in blood safety lab parameters reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in urine safety lab parameters
Délai: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in urine safety lab parameters reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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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
Autres numéros d'identification d'étude
- GLPG1837-CL-103
- 2015-002518-55 (Numéro EudraCT)
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