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Also known as ORX489 Tablets
ORX489 · 1 trial · 1 indication
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...
ORX489 is an investigational small molecule drug being developed by Centessa Pharmaceuticals plc. It is currently in Phase 1 clinical development, with one active trial evaluating it in healthy adult participants. The specific medical conditions it is intended to treat have not been disclosed.
ORX489 targets OX2R, the orexin receptor 2, which belongs to the receptor target class. As a small molecule, ORX489 is designed to interact with this receptor. The therapeutic area for which this mechanism is being developed has not been disclosed.
ORX489 is being developed by Centessa Pharmaceuticals plc, which trades under the ticker symbol CNTA. The company is the sponsor of the ongoing Phase 1 clinical trial for this asset.
ORX489 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial is currently recruiting participants.
ORX489 is being evaluated in a single Phase 1 trial, NCT07413666, titled A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years. The trial is currently recruiting, with an estimated enrollment of 212 participants in the United States.
Yes, ORX489 Tablets is an alternative name for ORX489. Both refer to the same investigational small molecule developed by Centessa Pharmaceuticals plc.