First-in-Human Single Ascending Dose of GLPG0492

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Galapagos NV
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects)

• BMI between 18-30 kg/m², inclusive

• non-smoker

Exclusion Criteria:

• elevated PSA

• drug or alcohol abuse