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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Galapagos NV
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• male, between 40 and 60 years of age, inclusive

• within BMI range 18 to 30 kg/m2, inclusive

Exclusion Criteria:

• Any condition that might interfere with the procedures or tests in this study

• Drug or alcohol abuse

• Smoking