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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02179502 | First-in-Human Single and Multiple Dose of GLPG1690 | PHASE1 | COMPLETED | 40 | — | — | Jun 1, 2014 | Dec 1, 2014 | Sep 22, 2015 | 1 | Belgium |
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after single and multiple oral dose in healthy subjects in terms of abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal vital signs
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal electrocardiogram
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal physical examination
| Arm | Type | Description |
|---|---|---|
| GLPG1690 single dose | EXPERIMENTAL | Single oral dose of GLPG1690 suspension or solid formulation - ascending doses |
| Placebo single dose | PLACEBO_COMPARATOR | Single oral dose of placebo suspension or solid formulation |
| GLPG1690 multiple doses | EXPERIMENTAL | Multiple oral doses of GLPG1690 suspension - ascending doses |
| Placebo multiple doses | PLACEBO_COMPARATOR | Multiple oral doses of placebo suspension |
| Name | Type | Description |
|---|---|---|
| GLPG1690 single ascending doses | DRUG | Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg |
| Placebo single ascending doses | DRUG | Single dose, oral suspension or solid formulation matching placebo |
| GLPG1690, multiple ascending doses, oral suspension | DRUG | Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg |
| 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