ORX489 safety and dosing in healthy adults ages 18 to 60
Official title: A Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults
Run by Centessa Pharmaceuticals (UK) Limited · NCT07413666 · Data updated 2026-11-12
This will test whether ORX489 tablets are safe, well tolerated, and how they are processed in the body in healthy men and women aged 18 to 60.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 212 (estimated) |
| Sponsor | Centessa Pharmaceuticals (UK) Limited Industry-sponsored |
| Locations | 1 site (Lincoln, Nebraska) |
| Status | Recruiting |
| Started | February 25, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | February 25, 2026 |
| Trial ID | NCT07413666 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy males and females aged 18–60 with no significant cardiac, pulmonary, hepatic, renal, hematologic, neurologic, endocrine, or psychiatric disease, and without clinically significant sleep disorders, are ideal candidates.
✕Probably not a fit
People with significant medical conditions, a history of seizures, or clinically significant sleep disorders (including insomnia or sleep apnea) would not be eligible and are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional trial gives single and multiple oral doses of ORX489 or matching placebo to healthy adult volunteers and monitors them closely. Participants are enrolled in sequential parts to characterize safety, tolerability, and pharmacokinetics using clinical assessments and blood sampling. Key exclusions include significant medical illnesses, seizure risk, or clinically significant sleep disorders. Dosing and follow-up take place at a clinical research unit operated by Celerion in Lincoln, Nebraska.
Why it matters
Potential benefit: If successful, the results could define a safe dose range and pharmacokinetic profile to support further development of ORX489 as an orexin-2 receptor agonist for sleep-wake disorders.
How similar studies have gone: Other orexin-2 receptor agonists have shown promising early-phase results in sleep disorder research, but ORX489 appears to be a novel compound undergoing first-in-human safety and PK testing.
Who can join: the full rules
Show full inclusion / exclusion criteria
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, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological, or psychiatric disease, as determined by medical history, physical examination, and screening investigations. * History of seizure disorder, any other condition that increases the risk of seizure * Has a clinically significant sleep disorder, including insomnia or sleep apnea
Where it's running
-
Celerion
Lincoln, Nebraska, United States Recruiting
Study contacts
- Study coordinator: ORX489 Centessa Program Lead ORX489 Centessa Program Lead
- Email: ORX489-101study@centessa.com
- Phone: 617-468-5770
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.