A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years

NCT07413666 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Protocol ORX489-101
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Male and Female Volunteers

Keywords

Healthy Volunteers orexin-2 receptor agonist

Outcome Measures

Primary Outcomes (4)

• Part A

  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.

  From enrollment to the Follow-Up Visit 7 days post-discharge

• Part B

  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

  From enrollment to the Follow-Up Visit 7 days post-discharge]

• Part C

  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

  From enrollment to the Follow-Up Visit 7 days post-discharge]

• Part D:

  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

  From enrollment to the Follow-Up Visit 7 days post-discharge

Secondary Outcomes (10)

• Cmax

  Pre-dose and multiple post-dose timepoints, up to 48 hours

• Tmax

  Pre-dose and multiple post-dose timepoints, up to 48 hours

• AUClast

  Pre-dose and multiple post-dose timepoints, up to 48 hours

• T 1/2 (terminal elimination half-life)

  Pre-dose and multiple post-dose timepoints, up to 48 hours

• Cmax

  Pre-dose and multiple post-dose timepoints, up to 48 hours

Study Arms (4)

Part A

EXPERIMENTAL

SAD Study in Healthy Adults: ORX489 and Placebo

Drug: ORX489 Tablets; Other: Placebo Tablets

Part B

EXPERIMENTAL

Food-effect Evaluation in Healthy Adults: ORX489

Drug: ORX489 Tablets

Part C

EXPERIMENTAL

MAD Study in Healthy Adults: ORX489 and Placebo

Drug: ORX489 Tablets; Other: Placebo Tablets

Part D

EXPERIMENTAL

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

Drug: ORX489 Tablets; Other: Placebo Tablets

Interventions

ORX489 Tablets DRUG

ORX489 Tablets

Part A; Part B; Part C; Part D

Placebo Tablets OTHER

Placebo Tablets

Part A; Part C; Part D

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centessa Pharmaceuticals (UK) Limited: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

RECRUITING

Central Study Contacts

ORX489 Centessa Program Lead ORX489 Centessa Program Lead

CONTACT

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

Celerion Program Lead CA49982 United States, Nebraska [Recruiting]

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind (investigator- and subject-blinded)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)