Drug-drug Interaction Study With GLPG3667 and Itraconazole 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 Itraconazole, a Strong CYP3A4 Inhibitor and Potent P-gp Inhibitor on the Pharmacokinetics of GLPG3667

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05272683
• Other study ID #: GLPG3667-CL-109
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2022
• Est. completion date: April 22, 2022

Study information

• Verified date: May 2022
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 22, 2022
• Est. primary completion date: April 1, 2022
• 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 (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.

This list only contains the key inclusion criteria.

Exclusion Criteria:

• 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.

This list only contains the key exclusion criteria.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG3667
On day 1 and day 8, participants will receive a single dose
• Itraconazole
On days 5 to 11, participants will receive itraconazole once daily

Locations

Country	Name	City	State
Canada	Altasciences	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation.	To evaluate the safety and tolerability of GLPG3667 alone or when co-administered with itraconazole	From Day 1 through study completion, an average of 2 months