NCT01208753

Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0555	two different aqueous formulations
DRUG	GLPG0555 aqueous	multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined
DRUG	placebo	multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-11-01
• Completion: 2011-02-01
• First posted: 2010-09-24
• Last updated: 2011-03-23

Locations

1 site across 1 country: Belgium