Healthy
Conditions
Brief summary
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2). Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.
Interventions
DRUGGLPG2222 single dose
single ascending doses, oral suspension
single doses, oral suspension, matching placebo
DRUGGLPG2222 multiple doses
multiple ascending doses, daily for 14 days, oral suspension
multiple doses, daily for 14 days, oral suspension, matching placebo
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Males between 18-50 years of age * Subjects must have a body mass index between 18-30 kg/m² * Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile * Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only)
Exclusion criteria
* A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug * Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study * A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration * Current sexually active (and/or child wish) male; a contraception method must be used
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change versus placebo in number of subjects with abnormal pulmonary function | Between screening and 4 days after the last dose (Part 1 only) | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry |
| Change versus placebo in number of subjects with abnormal vital signs | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs |
| Change versus placebo in number of subjects with abnormal electrocardiogram | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram |
| Change versus placebo in number of subjects with abnormal physical examination | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination |
| Change versus placebo in number of subjects with adverse events | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events |
| Change versus placebo in number of subjects with abnormal laboratory parameters | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The amount of GLPG2222 in urine | Between Day 1 predose and 24 hours after the (last) dose | To characterize the amount of GLPG2222 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects |
| Ratio of 6-b-hydroxycortisol/cortisol in urine | Twelve hours before dosing on Day 1 and Day 14 | To assess the potential of CYP3A4 interaction after repeated oral dosing with GLPG2222 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine |
| The amount of GLPG2222 in plasma | Between Day 1 predose and 48 hours after the (last) dose | To characterize the amount of GLPG2222 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects |
Countries
Belgium
Outcome results
None listed