Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food

A Randomized, Open-label, Two-way Cross-over Study to Determine the Oral Bioavailability of GLPG1205 After Single-dose Intake in Healthy Male Subjects as a Solid Formulation, With and Without Food

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 100 mg GLPG1205

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • SGS LSS Clinical Pharmacology Unit Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100 mg GLPG1205 fasted; Single dose of 100 mg GLPG1205 as two capsules of 50 mg after an overnight fast	Drug: 100 mg GLPG1205; A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
Experimental: 100 mg GLPG1205 fed; 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	Drug: 100 mg GLPG1205; A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of GLPG1205 in plasma	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.	From predose up to 504 hours (Day 22) after study drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of subjects with adverse events	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)	From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal laboratory parameters	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	From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal vital signs	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	From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal electrocardiogram (ECG)	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)	From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal physical examination	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	From screening up to 28 (+/-2) days after last study drug administration

Collaborators and Investigators

• Sponsor: Galapagos NV

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 18, 2014
• First Submitted That Met QC Criteria: May 18, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Estimate): July 22, 2014
• Last Update Submitted That Met QC Criteria: July 21, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: GLPG1205-CL-102; 2013-004771-12 (EudraCT Number)