Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 100 mg GLPG1205

• Registration Number: NCT02143856
• 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 oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects.

Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-18
• Study First Submitted QC: 2014-05-18
• Study First Posted: 2014-05-21
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
100 mg GLPG1205 fasted	100 mg GLPG1205	Single dose of 100 mg GLPG1205 as two capsules of 50 mg after an overnight fast
100 mg GLPG1205 fed	100 mg GLPG1205	Single dose of 100 mg GLPG1205 as two capsules of 50 mg exactly 30 minutes after the start of a high-fat, high-calorie breakfast

Primary Outcome Measures

Name	Time	Method
The amount of GLPG1205 in plasma	From predose up to 504 hours (Day 22) after study drug administration	To characterize and compare the amount of GLPG1205 in plasma ( relative bioavailability) in male healthy subjects after a single administration of a capsule formulation in a fasted versus fed condition.

Secondary Outcome Measures

Name	Time	Method
The number of subjects with adverse events	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of adverse events (AEs)
The number of subjects with abnormal laboratory parameters	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal laboratory parameters
The number of subjects with abnormal vital signs	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal vital signs
The number of subjects with abnormal electrocardiogram (ECG)	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal electrocardiogram (ECG)
The number of subjects with abnormal physical examination	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal physical examination

Trial Locations

Locations (1)

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