> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-orx142-in-healthy-adult-subjects-including-f657d792-d71d-49df-afb9-f3b14835a306 > Record changed: 2026-10-13 # A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age NCT07082829 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) Participants 208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) Lead sponsor Centessa Pharmaceuticals (UK) Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) Start date 2025-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Title and summary **Summary** Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Short title** A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Dates **Completion date** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **First posted** 2025-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Registry last updated** 2025-12-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Primary completion date** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Start date** 2025-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Size and sites **Participants** 208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Planned participants** 208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Lead sponsor** Centessa Pharmaceuticals (UK) Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Identifiers **Registry ID** NCT07082829 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **ClinicalTrials.gov ID** NCT07082829 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** Double-blind (investigator- and subject-blinded) **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Outcomes ### Primary outcomes 1. Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours 2. Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 Timeframe: 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 Timeframe: 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 Timeframe: 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. Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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. Timeframe: Part E: Day 2 10. Karolinska Sleepiness Scale score for ORX142 versus placebo Timeframe: Part E: Day 1-2 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** Yes 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Sites - Site #1Lincoln, United StatesRecruiting - Site #2Eatontown, United StatesRecruiting - Site #3New York, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07082829) ## Related records ### Drugs (1) - [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.md) ### Lead sponsors (1) - [Centessa Pharmaceuticals (UK) Limited](https://trialight.com/data/company/centessa-pharmaceuticals-uk-limited-624da423-7c8d-48e8-a012-b8d560eb1f9b.md) ### Targets (1) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. 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