drugset / Trial / NCT01798979

A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects

NCT01798979

Phase 1 Completed 20 enrolled Lakefront Biotherapeutics NV
NaSingle-groupOpen-labelTreatment

Summary

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of GLPG0634 (daily for 7 days). Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with midazolam in healthy male subjects will be evaluated.

Timeline

Start
2013-02
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Filgotinib Small molecule 200 mg Oral
Subject Midazolam Small molecule 2 mg Oral

Indications

No indication recorded.