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

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.

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