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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GLPG1205 and single CYP450 substrate cocktail dose

Daily GLPG1205 administration from Day 1 to Day 12 Single GLPG1205 co-administration on Day 13 with CYP450 substrate cocktail

Group Type EXPERIMENTAL

GLPG1205

Intervention Type DRUG

Once daily administration of 2 GLPG1205 capsules from Day 1 to Day 13

Cocktail of CYP450 substrates

Intervention Type DRUG

Single administration on Day 13 of cocktail of CYP450 substrates: warfarin tablet, omeprazole capsule and caffeine oral solution

Placebo and single CYP450 substrate cocktail dose

Daily Placebo administration from Day 1 to Day 12 Single Placebo co-administration on Day 13 with CYP450 substrate cocktail

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily administration of 2 matching placebo capsules from Day 1 to Day 13

Cocktail of CYP450 substrates

Intervention Type DRUG

Single administration on Day 13 of cocktail of CYP450 substrates: warfarin tablet, omeprazole capsule and caffeine oral solution

Interventions

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GLPG1205

Once daily administration of 2 GLPG1205 capsules from Day 1 to Day 13

Intervention Type DRUG

Placebo

Once daily administration of 2 matching placebo capsules from Day 1 to Day 13

Intervention Type DRUG

Cocktail of CYP450 substrates

Single administration on Day 13 of cocktail of CYP450 substrates: warfarin tablet, omeprazole capsule and caffeine oral solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes