Oral Bioavailability of Two Solid Formulations of GLPG0634

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 200 mg GLPG0634 as capsules, fasted; Drug: 200 mg GLPG0634 as tablets, fasted; Drug: 200 mg GLPG0634 as tablets, fed

• Registration Number: NCT01915667
• Lead Sponsor: Galapagos NV

Brief Summary

The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.

Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Healthy male, age 40-60 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GLPG0634 capsule fasted	200 mg GLPG0634 as capsules, fasted	Single dose of GLPG0634 as capsules in fasted condition
GLPG0634 tablet fasted	200 mg GLPG0634 as tablets, fasted	Single dose of GLPG0634 as tablets in fasted condition
GLPG0634 tablet fed	200 mg GLPG0634 as tablets, fed	Single dose of GLPG0634 as tablets in fed condition

Primary Outcome Measures

Name	Time	Method
The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets	From predose (before first study drug administration) up to 144 hours post last study drug administration	To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition.

Secondary Outcome Measures

Name	Time	Method
The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets	Between screening and 7-10 days after the last dose	To evaluate the safety and tolerability of GLPG0634 after a single oral dose as capsules or tablets, either fasted or fed, in male healthy subjects in terms of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs and electrocardiogram (ECG)

Trial Locations

Locations (1)

SGS LSS Clinical Pharmacology Unit Antwerp; 🇧🇪 Antwerp, Belgium