A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects

NCT ID: NCT01798979

Last Updated: 2013-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-04-30

Brief Summary

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of GLPG0634 (daily for 7 days).

Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with midazolam in healthy male subjects will be evaluated.

Conditions

Healthy

Study Design

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

Study Groups

Midazolam and GLPG0634

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8) and multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.

Midazolam

Intervention Type: DRUG

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8)

Interventions

GLPG0634

Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.

Intervention Type: DRUG

Midazolam

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• male, between 40 and 60 years of age, inclusive
• within BMI range 18 to 30 kg/m2, inclusive

Exclusion Criteria

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 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

Covance Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

GLPG0634-CL-103

Identifier Type: -

Identifier Source: org_study_id