Healthy Clinical Trial
Official title:
A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects
This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of
GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy
male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2
occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with
GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day
11).
Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with
midazolam in healthy male subjects will be evaluated.
A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.)
GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg
(500 mg b.i.d.) GLPG1837.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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