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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07413666 | A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years | PHASE1 | RECRUITING | 212 | — | — | Feb 25, 2026 | Jun 30, 2027 | Feb 25, 2026 | 1 | United States |
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in healthy adult participants.
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in the fasted and fed states
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral multiple ascending doses of ORX489 in healthy adult participants
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single oral doses of ORX489 in sleep-deprived healthy adult participants
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | SAD Study in Healthy Adults: ORX489 and Placebo |
| Part B | EXPERIMENTAL | Food-effect Evaluation in Healthy Adults: ORX489 |
| Part C | EXPERIMENTAL | MAD Study in Healthy Adults: ORX489 and Placebo |
| Part D | EXPERIMENTAL | SAD Study in Acutely Sleep-Deprived Healthy Adults: ORX489 and Placebo |
| Name | Type | Description |
|---|---|---|
| ORX489 Tablets | DRUG | ORX489 Tablets |
| Placebo Tablets | OTHER | Placebo Tablets |
Inclusion Criteria: * Healthy males or females as determined by assessments at the Screening Visit. * For Parts A, B, C, and D: Participants must be at least 18 years of age and no more than 60 years of age at the Screening Exclusion Criteria: * Presence of significant cardiac, pulmonary, gastroi...