First-in-Human Single Ascending and Multiple Dose of GLPG0634

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0634; Drug: placebo

• Registration Number: NCT01179581
• Lead Sponsor: Galapagos NV

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-10
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Status Verified: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-23
• Last Update Posted: 2011-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• healthy male, age 40-60 years
• body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria

• any condition that might interfere with the procedures or tests in the study
• smoking
• drug or alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GLPG0634	single ascending doses
2	placebo	single dose placebo
3	GLPG0634	multiple dose, 10 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily).
4	placebo	multiple dose, capsules, 10 days; scheme to match that of Study Arm 3.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single and multiple dosing	up to 10 days postdose	Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of single and repeated doses, including effect of food.	up to 10 days postdose	Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any "breakdown"-products of the drug are present (metabolism).

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium