NCT01130818

First-in-Human Single Ascending Dose of GLPG0492

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of GLPG0492 in Healthy Subjects and Open Relative Bioavailability Study of Oral Solution Versus Solid Formulation, Fasted and Fed, in Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0492	single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
DRUG	placebo	single dose, oral solution
DRUG	GLPG0492	single dose, solid formulation, 50 mg (2\*25 mg/capsule), fasting
DRUG	GLPG0492	single dose, solid formulation, 50 mg (2\*25 mg/capsule), after high fat breakfast

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2010-05-26
• Last updated: 2024-03-01

Locations

1 site across 1 country: Belgium