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

NCT04736927 | Completed Phase 1

• 2 other identifiers: GLPG3667-CL-1052020-004846-12
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MDZ

  To determine the effect of GLPG3667 on the pharmacokinetics (PK) of MDZ.

  From Day 1 until Day 9

• Maximum observed plasma concentration (Cmax) of MDZ

  To determine the effect of GLPG3667 on the PK of MDZ.

  From Day 1 until Day 9

Secondary Outcomes (4)

• Cmax of GLPG3667

  From Day 3 until Day 8

• Area under the plasma concentration-time curve over the dosing interval (AUCτ) for GLPG3667

  From Day 3 until Day 8

• Trough plasma concentration observed (Ct) for GLPG3667

  From Day 3 until Day 8

• Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.

  From Day 1 through study completion, an average of 3 weeks

Study Arms (1)

GLPG3667 + Midazolam

EXPERIMENTAL

Drug: GLPG3667; Drug: Midazolam

Interventions

GLPG3667 DRUG

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

GLPG3667 + Midazolam

Midazolam DRUG

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

GLPG3667 + Midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Natalia Rueda-Rincon, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: January 15, 2021
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)