A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age

NCT07082829 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ORX142-0101
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Excessive Daytime Sleepiness

Keywords

Excessive Daytime Sleepiness; orexin-2 receptor agonist

Outcome Measures

Primary Outcomes (5)

• Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects

  Safety and Tolerability as assessed by AEs and SAEs

  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

  Safety and Tolerability as assessed by AEs and SAEs

  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

  Safety and Tolerability as assessed by AEs and SAEs

  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

  Safety and Tolerability as assessed by AEs and SAEs

  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

  Safety and Tolerability as assessed by AEs and SAEs

  From enrollment to the Follow-Up Visit 13 days post-discharge

Secondary Outcomes (10)

• Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142

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

• Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142

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

• AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142

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

• T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142

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

• Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 in the fasted and fed state.

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

Study Arms (5)

Part A: SAD Study in Healthy Adults

EXPERIMENTAL

Drug: ORX142 Tablets; Other: Placebo Tablets

Part B: Food-effect Evaluation in Healthy Adults

EXPERIMENTAL

Drug: ORX142 Tablets

Part C: MAD Study in Healthy Adults

EXPERIMENTAL

Drug: ORX142 Tablets; Other: Placebo Tablets

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

EXPERIMENTAL

Drug: ORX142 Tablets; Other: Placebo Tablets

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

EXPERIMENTAL

Drug: ORX142 Tablets; Other: Placebo Tablets

Interventions

ORX142 Tablets DRUG

ORX142 Tablets

Part A: SAD Study in Healthy Adults; Part B: Food-effect Evaluation in Healthy Adults; Part C: MAD Study in Healthy Adults; Part D: Evaluation of a Single Dose in Healthy Older Adults; Part E: PoC Study in Acutely Sleep-deprived Healthy Adults

Placebo Tablets OTHER

Placebo Tablets

Part A: SAD Study in Healthy Adults; Part C: MAD Study in Healthy Adults; Part D: Evaluation of a Single Dose in Healthy Older Adults; Part E: PoC Study in Acutely Sleep-deprived Healthy Adults

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• For Part D:
• a .Participants must be at least 60 years of age and no more than 80 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 (3)

Site #1

Lincoln, Nebraska, 68502, United States

RECRUITING

Site #2

Eatontown, New Jersey, 07724, United States

RECRUITING

Site #3

New York, New York, 10019, United States

RECRUITING

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

ORX142 Centessa Program Lead

CONTACT

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

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: June 25, 2025
• First Posted: July 24, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)