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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cocktail of CYP450 substrates; Drug: GLPG1205; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02623296

GLPG1205-CL-103

2015-002785-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

GLPG1205 and single CYP450 substrate cocktail dose

Experimental group

Description:

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

Treatment:

Drug: GLPG1205

Drug: Cocktail of CYP450 substrates

Placebo and single CYP450 substrate cocktail dose

Placebo Comparator group

Description:

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

Treatment:

Drug: Cocktail of CYP450 substrates

Drug: Placebo