Drug-drug Interaction Study with GLPG3667 and Itraconazole in Healthy Subjects

NCT05272683 | Completed Phase 1

• 1 other identifier: GLPG3667-CL-109
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to determine the effect of itraconazole on the amount of GLPG3667 that gets into the blood when the 2 drugs are administered together compared to when GLPG3667 is administered alone.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum observed plasma concentration (Cmax) of GLPG3667

  To determine the effect of itraconazole on the pharmacokinetics (PK) of GLPG3667

  From Day 1 pre-dose until Day 12

• Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of GLPG3667

  To determine the effect of itraconazole on the PK of GLPG3667

  From Day 1 pre-dose until Day 12

Secondary Outcomes (1)

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

  From Day 1 through study completion, an average of 2 months

Study Arms (1)

GLPG3667 + itraconazole

EXPERIMENTAL

Drug: GLPG3667; Drug: Itraconazole

Interventions

GLPG3667 DRUG

On day 1 and day 8, participants will receive a single dose

GLPG3667 + itraconazole

Itraconazole DRUG

On days 5 to 11, participants will receive itraconazole once daily

GLPG3667 + itraconazole

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 (ICF). Female subjects should be of non-childbearing potential, defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilateral salpingectomy 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 (FSH) level in the postmenopausal range. 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. Neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator.

You may not qualify if:

• Known hypersensitivity to ingredients of GLPG3667 and/or itraconazole, or history of a significant allergic reaction to ingredients of GLPG3667 and/or itraconazole, as determined by the investigator.
• Treatment with any medication (including over-the-counter (OTC) 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

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Galapagos Study Director, 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: February 28, 2022
• First Posted: March 9, 2022
• Study Start: February 28, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 22, 2022
• Last Updated: September 19, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)