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Also known as GLPG3121 SAD, GLPG3121 MAD
GLPG3121 · 2 trials · 1 indication
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
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 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 |
| 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: * 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...