NCT01023321

First-in-Human Single Ascending and Multiple Dose of GLPG0555

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0555 in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 50 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 dose of GLPG0555 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0555	single ascending doses, oral solution
DRUG	placebo	single dose, oral solution
DRUG	GLPG0555	multiple dose, oral solution, 7 or 14 days
DRUG	placebo	multiple dose, oral solution, 7 or 14 days

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2009-12-02
• Last updated: 2010-08-12

Locations

1 site across 1 country: Belgium