NCT01798979

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

A Phase I, Open Interaction Study Between Oral Doses of GLPG0634 (200 mg QD) and Single Oral Doses of Midazolam (2 mg) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0634	Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.
DRUG	Midazolam	Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8)

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2013-02-26
• Last updated: 2013-05-07

Locations

1 site across 1 country: United States