A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 40 - 60 |
| Updated: | 3/30/2013 |
| Start Date: | February 2013 |
| End Date: | March 2013 |
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
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.
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
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