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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01887106 | First-in-Human Single and Multiple Dose of GLPG1205 | PHASE1 | COMPLETED | 40 | — | — | Jun 1, 2013 | Oct 1, 2013 | Oct 16, 2013 | 1 | Belgium |
To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after multiple oral doses daily for 14 days in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
| Arm | Type | Description |
|---|---|---|
| GLPG1205 single dose | EXPERIMENTAL | Single oral dose of GLPG1205 suspension - ascending doses |
| Placebo single dose | PLACEBO_COMPARATOR | Single oral dose of placebo suspension |
| GLPG1205 multiple doses | EXPERIMENTAL | Multiple oral doses of GLPG1205 suspension - ascending doses |
| Placebo multiple doses | PLACEBO_COMPARATOR | Multiple oral doses of placebo suspension |
| Name | Type | Description |
|---|---|---|
| GLPG1205 single ascending doses, oral suspension | DRUG | Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg |
| Placebo single ascending doses, oral suspension | DRUG | Single dose, oral suspension matching placebo |
| GLPG1205, multiple ascending doses, oral suspension | DRUG | Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg |
| Placebo, multiple ascending doses, oral suspension | DRUG | Multiple doses, daily for 14 days, oral suspension matching placebo |
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