ORX489 safety and dosing in healthy adults ages 18 to 60

A Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults

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: PHASE1
• Study type: Interventional
• Enrollment: 212 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Centessa Pharmaceuticals (UK) Limited (industry)
• Locations: 1 site (Lincoln, Nebraska)
• Trial ID: NCT07413666 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Lincoln, Nebraska

• Celerion — Lincoln, Nebraska, United States (RECRUITING)

Study contacts

• Study coordinator: ORX489 Centessa Program Lead ORX489 Centessa Program Lead

Conditions: Healthy Adult Male and Female Volunteers, Healthy Volunteers orexin-2 receptor agonist