Recruiting
Phase 1

ORX142

Sponsor:

Centessa Pharmaceuticals (UK) Limited

Code:

NCT07082829

Conditions

Excessive Daytime Sleepiness

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

ORX142 Tablets

Placebo Tablets

Study Details

Brief summary:

Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.

Conditions

Excessive Daytime Sleepiness

Study ID

NCT07082829

Start date

Jun 30, 2025

Status verified date

Dec, 2025

Completion date

Jun 15, 2026

Anticipated

Primary completion date

Jun 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Key Inclusion Criteria:

1. Healthy males or females as determined by assessments at the Screening Visit.

For Parts A, B, C, and E:

a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening
2. For Part D:

a .Participants must be at least 60 years of age and no more than 80 years of age at the Screening

Key Exclusion Criteria:

1. 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.
2. History of seizure disorder, any other condition that increases the risk of seizure
3. Has a clinically significant sleep disorder, including insomnia or sleep apnea.

Study Design

Enrollment

208 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: SAD Study in Healthy Adults

experimental: Part B: Food-effect Evaluation in Healthy Adults

experimental: Part C: MAD Study in Healthy Adults

experimental: Part D: Evaluation of a Single Dose in Healthy Older Adults

experimental: Part E: PoC Study in Acutely Sleep-deprived Healthy Adults

Interventions

ORX142 Tablets

ORX142 Tablets

Placebo Tablets

Placebo Tablets

Primary outcome measure

  • Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects [ Time Frame: From enrollment to the Follow-Up Visit 13 days post-discharge ]
  • Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states [ Time Frame: From enrollment to the Follow-Up Visit 13 days post-discharge ]
  • Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects [ Time Frame: From enrollment to the Follow-Up Visit 13 days post-discharge ]
  • Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects [ Time Frame: From enrollment to the Follow-Up Visit 13 days post-discharge ]
  • Part E: Incidence and severity of Treatment-Emergent Adverse Events of oral of single oral doses of ORX142 in acutely sleep-deprived healthy adult subjects [ Time Frame: From enrollment to the Follow-Up Visit 13 days post-discharge ]

Central Contacts and Locations

Central contacts

ORX142 Centessa Program Lead

617-468-5770ORX142-0101study@centessa.com

Locations

Site #1

Recruiting

Lincoln, Nebraska, United States, 68502

Site #2

Recruiting

Eatontown, New Jersey, United States, 07724

Site #3

Recruiting

New York, New York, United States, 10019

More Information

Sponsor

Centessa Pharmaceuticals (UK) Limited

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Excessive Daytime Sleepiness
  • 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 2025-12-24.