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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06542536 | A Research Study Investigating Safety and Concentration in the Blood After One Dose Tablet of the New Medicine Monlunabant in Healthy Weight Japanese and Caucasian Men | PHASE1 | COMPLETED | 73 | — | — | Aug 9, 2024 | Oct 25, 2024 | Nov 18, 2025 | 1 | United States |
Number of events
| Arm | Type | Description |
|---|---|---|
| Monlunabant dose 1 | EXPERIMENTAL | Dose 1 of monlunabant treatment |
| Monlunabant dose 2 | EXPERIMENTAL | Dose 2 of monlunabant treatment |
| Monlunabant dose 3 | EXPERIMENTAL | Dose 3 of the monlunabant treatment |
| Placebo (monlunabant) | PLACEBO_COMPARATOR | Placebo treatment |
| Name | Type | Description |
|---|---|---|
| Monlunabant | DRUG | Oral monlunabant |
| Placebo (monlunabant) | DRUG | Oral placebo (monlunabant) |
Inclusion Criteria: * Male. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit,...