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 GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized. The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated. The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.
Interventions
DRUGGLPG1837 single ascending doses
Single dose, oral suspension
Single dose, oral suspension matching placebo
DRUGGLPG1837 multiple ascending doses
Multiple 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
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females of non-child bearing potential between 18-50 years of age (included) * Subjects must have a body mass index between 18-30 kg/m² (included) * 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 findings
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 or participation within 15 weeks prior to initial study drug administration in an investigational research study with antibody administration * 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 should be used * Pregnant or lactating women or women of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with abnormal physical examination | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination |
| Number of subjects with abnormal laboratory parameters | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters |
| Number of subjects with abnormal vital signs | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs |
| Number of subjects with abnormal electrocardiogram | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms |
| Number of subjects with adverse events | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The amount of GLPG1837 and its metabolite in urine | Between Day 1 predose and 24 hours after the (last) dose | To characterize the amount of GLPG1837 and its metabolite in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed |
| Ratio of 6-b-hydroxycortisol/cortisol in urine | Twelve hours before dosing on Day 1 and Day 14 | To assess the potential of CYP3A4 induction after repeated oral dosing with GLPG1837 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine |
| The amount of GLPG1837 and its metabolite in plasma | Between Day 1 predose and 48 hours after the (last) dose | To characterize the amount of GLPG1837 and its metabolite in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed |
Countries
Belgium
Outcome results
None listed