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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04653467 | A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult Subjects | PHASE1 | COMPLETED | 88 | — | — | Nov 6, 2020 | Jan 10, 2022 | Feb 1, 2022 | 1 | Canada |
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG4399 in adult, healthy, male subjects.
| Arm | Type | Description |
|---|---|---|
| GLPG4399 SAD | EXPERIMENTAL | Single doses of GLPG4399 at up to 6 dose levels in ascending order |
| Placebo SAD | PLACEBO_COMPARATOR | Single doses of placebo |
| GLPG4399 MAD | EXPERIMENTAL | Multiple ascending doses of GLPG4399 |
| Placebo MAD | PLACEBO_COMPARATOR | Multiple doses of placebo |
| GLPG4399 FE-rBA | EXPERIMENTAL | Single dose of GLPG4399 in fed and fasted state |
| GLPG4399 FE | EXPERIMENTAL | Single dose of GLPG4399 in fed and fasted state |
| Name | Type | Description |
|---|---|---|
| GLPG4399 oral suspension | DRUG | GLPG4399 for oral administration |
| GLPG4399 capsules | DRUG | GLPG4399 for oral administration |
| Placebo | DRUG | Placebo oral suspension |
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...