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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04856358 | A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects | PHASE1 | COMPLETED | 50 | — | — | Apr 27, 2021 | Nov 8, 2021 | Sep 19, 2024 | 1 | Germany |
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121-modified-release formulation (GLPG3121-MR), in adult, healthy, male subjects compared with placebo
| Arm | Type | Description |
|---|---|---|
| GLPG3121 SAD | EXPERIMENTAL | Single doses of GLPG3121 at up to 3 dose levels in ascending order |
| Placebo SAD | PLACEBO_COMPARATOR | Single doses of placebo |
| GLPG3121 MAD | EXPERIMENTAL | Multiple doses of GLPG3121 at up to 3 dose levels in ascending order |
| Placebo MAD | PLACEBO_COMPARATOR | Multiple doses of placebo |
| GLPG3121 FE fed | EXPERIMENTAL | Single dose of GLPG3121 in fed state |
| GLPG3121 FE fasted | EXPERIMENTAL | Single dose of GLPG3121 in fasted state |
| Name | Type | Description |
|---|---|---|
| GLPG3121 | DRUG | GLPG3121 modified-release tablet |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: * Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). * A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. * Judged to be in good health by the investigator based upon the results of a medical history, phy...