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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02325037 | First-in-Human Single and Multiple Dose of GLPG1837 | PHASE1 | COMPLETED | 64 | — | — | Dec 1, 2014 | Sep 1, 2015 | Sep 9, 2015 | 1 | Belgium |
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination
| Arm | Type | Description |
|---|---|---|
| GLPG1837 single dose | EXPERIMENTAL | Single oral dose of GLPG1837 suspension - ascending doses |
| Placebo single dose | PLACEBO_COMPARATOR | Single oral dose of placebo suspension |
| GLPG1837 muliple doses | EXPERIMENTAL | Multiple oral doses of GLPG1837 suspension - ascending doses |
| Placebo multiple doses | PLACEBO_COMPARATOR | Multiple oral doses of placebo suspension |
| Name | Type | Description |
|---|---|---|
| GLPG1837 single ascending doses | DRUG | Single dose, oral suspension |
| Placebo single dose | DRUG | Single dose, oral suspension matching placebo |
| GLPG1837 multiple ascending doses | DRUG | Multiple doses, daily for 14 days, oral suspension |
| Placebo multiple doses | DRUG | Multiple doses, daily for 14 days, oral suspension, matching placebo |
Inclusion Criteria: * Males or females of non-child bearing potential between 18-50 years of age (included) * Subjects must have a body mass index between 18-30 kg/m² (included) * Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital s...