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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03899909 | A Study to Evaluate the Effects of a Single and Multiple Oral Doses of GLPG3121 in Adult, Healthy, Male Subjects | PHASE1 | COMPLETED | 31 | — | — | Mar 29, 2019 | Jun 3, 2019 | Jul 5, 2019 | 1 | Belgium |
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects compared with placebo.
| Arm | Type | Description |
|---|---|---|
| GLPG3121 SAD | EXPERIMENTAL | Single doses of GLPG3121 at up to 6 dose levels in ascending order |
| Placebo SAD | PLACEBO_COMPARATOR | Single doses of placebo |
| GLPG3121 MAD | EXPERIMENTAL | Multiple doses of GLPG3121 at up to 4 dose levels in ascending order |
| Placebo MAD | PLACEBO_COMPARATOR | Multiple doses of placebo |
| Name | Type | Description |
|---|---|---|
| GLPG3121 SAD | DRUG | GLPG3121 oral suspension, single ascending doses |
| Placebo SAD | DRUG | Placebo oral suspension |
| GLPG3121 MAD | DRUG | GLPG3121 oral suspension, multiple ascending doses, daily for 13 days |
| Placebo MAD | DRUG | Placebo oral suspension, daily for 13 days |
Inclusion Criteria: * Able and willing to comply with the protocol requirements and signing the Informed Consent Form (ICF) as approved by the Independent Ethical Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations. * Male between 18 to 55 years of age (extremes inc...