NCT01336244

GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0778 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (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 GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0778	capsules containing 50 or 100 mg of GLPG0778
DRUG	placebo	multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2011-04-15
• Last updated: 2011-10-18

Locations

1 site across 1 country: Belgium