drugset / Trial / NCT01130818

First-in-Human Single Ascending Dose of GLPG0492

NCT01130818 ↗

Phase 1 Completed 28 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start
2010-05
Primary completion
2010-08
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject GLPG0492 Small molecule 25 mg Oral
Subject GLPG0492 Small molecule 50 mg Oral
Subject GLPG0492 Small molecule 120 mg Oral

Indications

No indication recorded.