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NCT Number: NCT07082829

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

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

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Key information

Conditions

Excessive Daytime Sleepiness Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site #1, Lincoln, Nebraska, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key 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.

Treatment and study plan

ORX142 Tablets

Drug

ORX142 Tablets

Placebo tablets

Other

Placebo Tablets

Primary outcomes

  1. 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

    Safety and Tolerability as assessed by AEs and SAEs

  2. 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

    Safety and Tolerability as assessed by AEs and SAEs

  3. 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

    Safety and Tolerability as assessed by AEs and SAEs

  4. 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

    Safety and Tolerability as assessed by AEs and SAEs

  5. 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

    Safety and Tolerability as assessed by AEs and SAEs

Secondary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142

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

  2. Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142

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

  3. 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

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

  4. 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

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

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

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

  6. Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state

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

  7. 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 in the fast and fed state

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

  8. 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 in the fast and fed state

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

  9. Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX142 versus placebo.

    Time frame: Part E: Day 2

  10. Karolinska Sleepiness Scale score for ORX142 versus placebo

    Time frame: Part E: Day 1-2

Study contacts

Contact information is provided by the study sponsor or research team.

ORX142 Centessa Program Lead

CONTACT

[email protected]

617-468-5770

Sponsors and collaborators

Lead sponsor

Centessa Pharmaceuticals (UK) Limited

Industry

Registry information

Official study title

A Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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