Overview

A Drug-drug Interaction Study Between GLPG1205 and a Cocktail of CYP450 Substrates in Healthy Male Subjects

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
Male
Summary
This will be a Phase I, randomized, double-blind, placebo-controlled, 2 period cross-over, drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1205 or placebo (daily from Day 1 to Day 12) on a single dose pharmacokinetic profile of a cocktail of CYP450 substrates administered to healthy male subjects. The cocktail of CYP450 substrates will consist of 10 mg warfarin (CYP2C9 substrate), 20 mg omeprazole (CYP2C19 substrate) and 100 mg caffeine (CYP1A2 substrate). Fourteen healthy male subjects will receive during two treatment periods from Day 1 to Day 12 a daily dose of GLPG1205 or placebo. On Day 13, a single dose of the cocktail of CYP450 substrates will be co-administered either with GLPG1205 or with placebo. The two treatment periods will be separated by a wash-out period of at least 28 days. Also, the safety and tolerability of multiple oral doses of GLPG1205 administered with or without a cocktail of CYP450 substrates in healthy male subjects will be evaluated.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Galapagos NV
Criteria
Inclusion Criteria:

- healthy male, age 18-50 years

- BMI between 18-30 kg/m2

Exclusion Criteria:

- Poor or moderate metabolizer for CYP2C9 or CYP2C19 as determined by genotyping

- Having a contraindication as indicated in the respective Summary of Product
Characteristics (or Package Leaflets) for warfarin, omeprazole or caffeine

- Intake of nutraceuticals within 3 weeks prior to dosing or within 6 times the
elimination half life

- Intake of enzyme inducing or enzyme inhibiting drugs within 3 months prior to dosing

- Intake of vitamin K within 3 weeks prior to dosing

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

- Drug or alcohol abuse

- Smoking