Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01915667 | Oral Bioavailability of Two Solid Formulations of GLPG0634 | PHASE1 | COMPLETED | 12 | — | — | Jul 1, 2013 | Sep 1, 2013 | Sep 17, 2013 | 1 | Belgium |
To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition.
| Arm | Type | Description |
|---|---|---|
| GLPG0634 capsule fasted | EXPERIMENTAL | Single dose of GLPG0634 as capsules in fasted condition |
| GLPG0634 tablet fasted | EXPERIMENTAL | Single dose of GLPG0634 as tablets in fasted condition |
| GLPG0634 tablet fed | ACTIVE_COMPARATOR | Single dose of GLPG0634 as tablets in fed condition |
| Name | Type | Description |
|---|---|---|
| 200 mg GLPG0634 as capsules, fasted | DRUG | single oral dose of 200 mg GLPG0634 given as capsules in fasted condition |
| 200 mg GLPG0634 as tablets, fasted | DRUG | single oral dose of 200 mg GLPG0634 given as tablets in fasted condition |
| 200 mg GLPG0634 as tablets, fed | DRUG | single oral dose of 200 mg GLPG0634 given as tablets in fed condition |
Inclusion Criteria: * Healthy male, age 40-60 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