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 GLPG1972 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 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 GLPG1972 present in the blood and urine (pharmacokinetics) will be characterized. The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored as well. During the course of the study after multiple oral dose administrations, the effect of GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.
Interventions
DRUGGLPG1972 single ascending doses
single dose, oral solution
single dose, oral solution, matching placebo
DRUGGLPG1972 multiple ascending doses
multiple doses, daily for 14 days, oral solution
multiple doses, daily for 14 days, oral solution
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
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 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 should be used
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms |
| 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 GLPG1972 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 GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters |
| 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 GLPG1972 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 physical examination | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The amount of GLPG1972 in plasma | Between Day 1 predose and 48 hours after the (last) dose | To characterize the amount of GLPG1972 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed |
| The amount of GLPG1972 in urine | Between Day 1 predose and 24 hours after the (last) dose | To characterize the amount of GLPG1972 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 interaction after repeated oral dosing with GLPG1972 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine |
| Levels of GLPG1972 biomarker in blood | Between Day 1 predose and 48 hours after the last dose | To assess the pharmacodynamics (PD) of GLPG1972 by means of reduction of levels of biomarker in blood by GLPG1972 compared to placebo after repeated oral dosing |
Countries
Belgium
Outcome results
None listed