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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02562859 | Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food | PHASE1 | COMPLETED | 12 | — | — | Sep 1, 2015 | Oct 1, 2015 | Oct 23, 2015 | 1 | Belgium |
To characterize and compare the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the area under the plasma concentration versus time curve of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the apparent terminal half-life of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the metabolite over GLPG1837 ratios in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
| Arm | Type | Description |
|---|---|---|
| GLPG1837 as oral suspension fasted | EXPERIMENTAL | Single dose of 500 mg GLPG1837 as oral suspension after an overnight fast |
| GLPG1837 as oral tablet fasted | EXPERIMENTAL | Single dose of 500 mg GLPG1837 as oral tablet after an overnight fast |
| GLPG1837 as oral tablet fed | EXPERIMENTAL | Single dose of 500 mg GLPG1837 as oral tablet after a high-fat high-calorie breakfast |
| Name | Type | Description |
|---|---|---|
| 500 mg GLPG1837 as oral suspension | DRUG | A single dose of 500 mg GLPG1837 administered as oral suspension |
| 500 mg GLPG1837 as oral tablet | DRUG | A single dose of 500 mg GLPG1837 administered as oral tablet |
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