NCT01179581

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

Double-blind Placebo-controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG0634 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0634	single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose)
DRUG	placebo	single dose, oral solution or capsule (matching corresponding study medication)
DRUG	GLPG0634	multiple dose, capsule, 10 days
DRUG	placebo	multiple dose, capsule, 10 days

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-08-11
• Last updated: 2011-03-24

Locations

1 site across 1 country: Belgium