Healthy
Conditions
Brief summary
The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects. Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.
Interventions
DRUGGLPG0634 50 mg
2 tablets of 25 mg GLPG0634 once daily for 10 days
DRUGGLPG0634 100 mg
1 tablet of 100 mg GLPG0634 once daily for 10 days
DRUGGLPG0634 200 mg
2 tablets of 100 mg GLPG0634 once daily for 10 days
DRUGPlacebo
1 or 2 matching placebo tablets once daily for 10 days
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female Japanese or Caucasian subjects between 20-65 years of age (included) * Subjects must have a body mass index between 18-28 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 profile
Exclusion criteria
* A subject with a known hypersensitivity to ingredients of the study drug or a significant allergic reaction to any drug * Concurrent participation or participation within 3 months 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 * Subject expresses current desire to have (more) children * Female subject is less than 6 months post-partum, post-abortion or post lactation prior to study drug administration or is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects with abnormal vital signs | From screening up to 10 days after last dose (Day 20) | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal vital signs |
| The number of subjects with adverse events | From screening up to 10 days after last dose (Day 20) | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of adverse events (AEs) |
| The number of subjects with abnormal laboratory parameters | From screening up to 10 days after last dose (Day 20) | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal laboratory parameters |
| The amount of GLPG0634 and metabolite in plasma and urine | Between Day 1 before dosing and Day 13 (72 hours after last dose) | To characterize the amount of GLPG0634 and metabolite in plasma and urine over time - pharmacokinetics (PK) - in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested Safety Issue?: No |
| The number of subjects with abnormal electrocardiogram | From screening up to 10 days after last dose (Day 20) | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal electrocardiogram |
| The number of subjects with abnormal physical examination | From screening up to 10 days after last dose (Day 20) | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal physical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The amount of GLPG0634 mechanism-of-action-related biomarkers in blood | Between Day 1 before dosing and Day 11 (24 hours after last dose) | To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested |
Countries
United Kingdom
Outcome results
None listed