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 GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to healthy male 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 GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo. The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.
Interventions
DRUGGLPG1690 single ascending doses
Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg
DRUGPlacebo single ascending doses
Single dose, oral suspension or solid formulation matching placebo
DRUGGLPG1690, multiple ascending doses, oral suspension
Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg
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
* Healthy male, age 18-50 years * BMI between 18-30 kg/m2
Exclusion criteria
* Any condition that might interfere with the procedures or tests in this study * Drug or alcohol abuse * Smoking
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 GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal physical examination |
| Number of subjects with adverse events | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events |
| Number of subjects with abnormal laboratory parameters | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after single and multiple oral dose 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 GLPG1690 in comparison with placebo after a single and multiple oral dose 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 GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal electrocardiogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The amount of GLPG1690 in urine | Between Day 1 predose and 24 hours after the (last) dose | To characterize the amount of GLPG1690 in urine over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation |
| 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 dosing with GLPG1690 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine |
| Levels of biomarker in plasma | Day 1 predose up to 48 hours post (last) dose | To characterize the pharmacodynamics (PD) of GLPG1690 by means of reduction of levels of biomarker by GLPG1690 compared to placebo in plasma after single and multiple oral dose in healthy subjects |
| The amount of GLPG1690 in plasma | Between Day 1 predose and 48 hours after the (last) dose | To characterize the amount of GLPG1690 in plasma over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation |
Countries
Belgium
Outcome results
None listed