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

An Open-label, Fixed-sequence, Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of GLPG3667 on the Pharmacokinetics of Midazolam, a Sensitive Index Substrate of CYP3A4

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG3667; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

This list only contains the key inclusion criteria.

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.

This list only contains the key exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLPG3667 + Midazolam	Drug: GLPG3667; From Day 3 to Day 8, GLPG3667 capsules q.d. orally in fed state.; Drug: Midazolam; On Day 1 and Day 7 as liquid formulation, orally in fed state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of GLPG3667	To evaluate the PK of GLPG3667 in the presence of a single dose of MDZ.	From Day 3 until Day 8
Area under the plasma concentration-time curve over the dosing interval (AUCτ) for GLPG3667	To evaluate the PK of GLPG3667 in the presence of a single dose of MDZ.	From Day 3 until Day 8
Trough plasma concentration observed (Ct) for GLPG3667	To evaluate the PK of GLPG3667 in the presence of a single dose of MDZ.	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.	To evaluate the safety and tolerability of GLPG3667 alone or when coadministered with MDZ.	From Day 1 through study completion, an average of 3 weeks

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Natalia Rueda-Rincon, MD, Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): February 25, 2021
• Study Completion (Actual): February 25, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: GLPG3667-CL-105; 2020-004846-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No