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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736927
• Other study ID #: GLPG3667-CL-105
• Secondary ID: 2020-004846-12
• Status: Completed
• Phase: Phase 1
• Start date: January 15, 2021
• Est. completion date: February 25, 2021

Study information

• Verified date: March 2021
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG3667
From Day 3 to Day 8, GLPG3667 capsules q.d. orally in fed state.
• Midazolam
On Day 1 and Day 7 as liquid formulation, orally in fed state.

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cmax of GLPG3667	To evaluate the PK of GLPG3667 in the presence of a single dose of MDZ.	From Day 3 until Day 8
Secondary	Area under the plasma concentration-time curve over the dosing interval (AUCt) for GLPG3667	To evaluate the PK of GLPG3667 in the presence of a single dose of MDZ.	From Day 3 until Day 8
Secondary	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
Secondary	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