Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects

NCT ID: NCT05030857

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2021-11-13

Brief Summary

The purpose of this study is to determine the effect of the administration of multiple doses of GLPG4716 on the amount of midazolam (MDZ) that gets into the blood when the two drugs are administered together compared to when midazolam is administered alone. Other objectives of this study are to evaluate the safety and tolerability of GLPG4716 when administered with midazolam and assess the amount of GLPG4716 that gets into the blood when administered with midazolam. This study will also assess the effect of food on the amount of GLPG4716 that gets into the blood.

Conditions

Healthy

Study Design

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

Study Groups

GLPG4716 and Midazolam

Group Type: EXPERIMENTAL

GLPG4716

Intervention Type: DRUG

From Day 3 to Day 14, participants will receive GLPG4716 tablets once daily in fasted state. On Day 8 GLPG4716 will be administered in fed state.

Midazolam

Intervention Type: DRUG

On Days 1, 3 and 13, participants will receive a single oral dose of MDZ as an oral solution in fasted state.

Interventions

GLPG4716

From Day 3 to Day 14, participants will receive GLPG4716 tablets once daily in fasted state. On Day 8 GLPG4716 will be administered in fed state.

Intervention Type: DRUG

Midazolam

On Days 1, 3 and 13, participants will receive a single oral dose of MDZ as an oral solution in fasted state.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form. Female subjects should be of non-childbearing potential.
• A body mass index between 18.0 and 30.0 kg/m2, inclusive.
• Judged to be in good health by the investigator based upon:

• The results of a medical history
• Physical examination
• Vital signs
• Oxygen saturation
• 12-lead electrocardiogram
• Fasting clinical laboratory safety tests. Aspartate aminotransferase and alanine aminotransferase must be no greater than 1.5x upper limit of normal range and total bilirubin no greater than 1x upper limit of normal. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

Exclusion Criteria

• Known hypersensitivity to ingredients of GLPG4716 and/or MDZ
• History of a significant allergic reaction to ingredients of GLPG4716 and/or MDZ as determined by the investigator.
• Treatment with any medication including:

• Over-the-counter and/or prescription medication
• Dietary supplements
• Nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy
• Except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia Rueda-Rincon, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Altasciences

Montreal, , Canada

Countries

Canada

Other Identifiers

GLPG4716-CL-102

Identifier Type: -

Identifier Source: org_study_id