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

NCT05030857 | Completed Phase 1

• 1 other identifier: GLPG4716-CL-102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Maximum observed plasma concentration (Cmax) of MDZ

  To determine the effect of GLPG4716 on the pharmacokinetics (PK) of MDZ

  From Day 1 pre-dose until Day 15

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

  To determine the effect of GLPG4716 on the PK of MDZ

  From Day 1 pre-dose until Day 15

Secondary Outcomes (3)

• Cmax of GLPG4716

  From Day 1 pre-dose until Day 15

• Area under the plasma concentration-time curve over the dosing interval (AUCt) of GLPG4716

  From Day 1 pre-dose until Day 15

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

  From Day 1 through study completion, an average of one month

Study Arms (1)

GLPG4716 and Midazolam

EXPERIMENTAL

Drug: GLPG4716; Drug: Midazolam

Interventions

GLPG4716 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.

GLPG4716 and Midazolam

Midazolam DRUG

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

GLPG4716 and 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.
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Altasciences

Montreal, QC H3P 3P1, Canada

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: August 30, 2021
• First Posted: September 1, 2021
• Study Start: September 8, 2021
• Primary Completion: November 13, 2021
• Study Completion: November 13, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)