A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects

NCT ID: NCT02562950

Last Updated: 2015-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-10-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Midazolam and 500 mg GLPG1837

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.

Group Type: EXPERIMENTAL

GLPG1837 500 mg

Intervention Type: DRUG

Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.

Midazolam

Intervention Type: DRUG

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).

Midazolam and 1000 mg GLPG1837

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).

GLPG1837 1000 mg

Intervention Type: DRUG

Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.

Interventions

GLPG1837 500 mg

Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.

Intervention Type: DRUG

Midazolam

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).

Intervention Type: DRUG

GLPG1837 1000 mg

Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• healthy male, age 18-50 years
• BMI between 18-30 kg/m2

Exclusion Criteria

• 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

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Vanhoutte, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Countries

Belgium

Other Identifiers

2015-002517-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG1837-CL-102

Identifier Type: -

Identifier Source: org_study_id