Recruiting
Phase 1

ORX489

Sponsor:

Centessa Pharmaceuticals (UK) Limited

Code:

NCT07413666

Conditions

Healthy Adult Male and Female Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

ORX489 Tablets

Placebo Tablets

Study Details

Brief summary:

Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.

Conditions

Healthy Adult Male and Female Volunteers

Study ID

NCT07413666

Start date

Feb 25, 2026

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

212 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A

SAD Study in Healthy Adults: ORX489 and Placebo

experimental: Part B

Food-effect Evaluation in Healthy Adults: ORX489

experimental: Part C

MAD Study in Healthy Adults: ORX489 and Placebo

experimental: Part D

SAD Study in Acutely Sleep-Deprived Healthy Adults: ORX489 and Placebo

Interventions

ORX489 Tablets

ORX489 Tablets

Placebo Tablets

Placebo Tablets

Primary outcome measure

  • Part A [ Time Frame: From enrollment to the Follow-Up Visit 7 days post-discharge ]
  • Part B [ Time Frame: From enrollment to the Follow-Up Visit 7 days post-discharge] ]
  • Part C [ Time Frame: From enrollment to the Follow-Up Visit 7 days post-discharge] ]
  • Part D: [ Time Frame: From enrollment to the Follow-Up Visit 7 days post-discharge ]

Central Contacts and Locations

Central contacts

ORX489 Centessa Program Lead ORX489 Centessa Program Lead

617-468-5770ORX489-101study@centessa.com

Locations

Celerion

Recruiting

Lincoln, Nebraska, United States, 68502

More Information

Sponsor

Centessa Pharmaceuticals (UK) Limited

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • Healthy Volunteers orexin-2 receptor agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centessa Pharmaceuticals (UK) Limited on 2026-02-25.