Drug-drug Interaction Study With GLPG3667 and Itraconazole in Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GLPG3667 + itraconazole
|
Drug: GLPG3667
On day 1 and day 8, participants will receive a single dose
Drug: Itraconazole
On days 5 to 11, participants will receive itraconazole once daily
|
Outcome Measures
Primary Outcome Measures
- Maximum observed plasma concentration (Cmax) of GLPG3667 [From Day 1 pre-dose until Day 12]
To determine the effect of itraconazole on the pharmacokinetics (PK) of GLPG3667
- Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of GLPG3667 [From Day 1 pre-dose until Day 12]
To determine the effect of itraconazole on the PK of GLPG3667
Secondary Outcome Measures
- 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]
To evaluate the safety and tolerability of GLPG3667 alone or when co-administered with itraconazole
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Altasciences | Montréal | Canada | QC H3P 3P1 |
Sponsors and Collaborators
- Galapagos NV
Investigators
- Study Director: Galapagos Study Director, MD, Galapagos NV
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLPG3667-CL-109