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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 being studied in healthy adult male and female volunteers. It is currently in Phase 1 clinical development, with a single trial recruiting participants aged 18 to 60 years in the United States. The drug is not approved and remains under investigation.
ORX489 targets the OX2R receptor, also known as the orexin 2 receptor. As a small molecule designed to interact with this receptor, it is being evaluated in early-stage clinical trials. The specific therapeutic application is still under investigation in healthy volunteers.
ORX489 is being developed by Centessa Pharmaceuticals plc, a biopharmaceutical company traded on the stock exchange under the ticker CNTA. The company is conducting a Phase 1 clinical trial of ORX489 in healthy adult participants in the United States.
ORX489 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 study is recruiting healthy adult participants to evaluate the drug's safety and tolerability.
ORX489 is being studied in a single Phase 1 clinical trial with the identifier NCT07413666, titled "A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years." This randomized, double-blind, controlled trial is recruiting 212 healthy volunteers in the United States.
Yes, ORX489 is also known as ORX489 Tablets. Both names refer to the same investigational drug being developed by Centessa Pharmaceuticals. The tablet formulation is currently being evaluated in a Phase 1 clinical trial in healthy adult participants.