Clinical trial NCT05030857: Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
Official title: An Open-label, Fixed Sequence, Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of GLPG4716 on the Pharmacokinetics of Midazolam, a Sensitive Index Substrate of CYP3A4, and to Assess the Effect of Food on the Pharmacokinetics of GLPG4716
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2021-09-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

This list only contains the key inclusion criteria.

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.

This list only contains the key exclusion criteria.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of MDZ
timeFrame: From Day 1 pre-dose until Day 15
measure: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MDZ
timeFrame: From Day 1 pre-dose until Day 15
Secondary outcomes:
measure: Cmax of GLPG4716
timeFrame: From Day 1 pre-dose until Day 15
measure: Area under the plasma concentration-time curve over the dosing interval (AUCt) of GLPG4716
timeFrame: From Day 1 pre-dose until Day 15
measure: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent (SAEs), and TEAEs leading to treatment discontinuations
timeFrame: From Day 1 through study completion, an average of one month
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Altasciences
Study officials:
affiliation: Galapagos NV
name: Natalia Rueda-Rincon, MD
role: STUDY_DIRECTOR
References: