Drug-drug Interaction Study With GLPG3667 and Midazolam in Healthy Subjects

NCT ID: NCT04736927

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-02-25

Brief Summary

A study in healthy volunteers to look at the effect of the test medicine, GLPG3667, on how midazolam (MDZ) is taken up and eliminated by the body.

Conditions

Healthy

Study Design

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

Study Groups

GLPG3667 + Midazolam

Group Type: EXPERIMENTAL

GLPG3667

Intervention Type: DRUG

From Day 3 to Day 8, GLPG3667 capsules q.d. orally in fed state.

Midazolam

Intervention Type: DRUG

On Day 1 and Day 7 as liquid formulation, orally in fed state.

Interventions

GLPG3667

From Day 3 to Day 8, GLPG3667 capsules q.d. orally in fed state.

Intervention Type: DRUG

Midazolam

On Day 1 and Day 7 as liquid formulation, orally in fed 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, defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilateral salpingectomy, i.e. surgical removal of the fallopian tubes, or hysterectomy, i.e. surgical removal of uterus), or with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone level in the postmenopausal range. These female subjects must also have a negative pregnancy test. For surgical sterilization, documented confirmation will be requested.
• 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, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests available at screening and prior to enrolment. Neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase, and alanine aminotransferase must be within normal ranges. 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 investigational product (IP) and/or MDZ ingredients or history of a significant allergic reaction to IP and/or MDZ ingredients 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 for postmenopausal subjects) 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

Quotient Sciences

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2020-004846-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG3667-CL-105

Identifier Type: -

Identifier Source: org_study_id