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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02562950 | A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2015 | Oct 1, 2015 | Oct 23, 2015 | 1 | Belgium |
To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects
To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects
To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
| Arm | Type | Description |
|---|---|---|
| Midazolam and 500 mg GLPG1837 | EXPERIMENTAL | Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11. |
| Midazolam and 1000 mg GLPG1837 | EXPERIMENTAL | Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12. |
| Name | Type | Description |
|---|---|---|
| GLPG1837 500 mg | DRUG | Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12. |
| Midazolam | DRUG | Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12). |
| GLPG1837 1000 mg | DRUG | Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12. |
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