drugset / Trial / NCT01721980

Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

NCT01721980 ↗

Phase 1 Completed 32 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo. Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo. Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.

Timeline

Start
2012-10
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject GLPG0974 Small molecule 50 mg Oral
Subject GLPG0974 Small molecule 100 mg Oral
Subject GLPG0974 Small molecule 200 mg Oral
Subject GLPG0974 Small molecule 400 mg Oral

Indications

No indication recorded.