> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-orx489-in-healthy-adult-participants-aged-18-to-08dea0f1-1e15-41fa-b670-1be7caf03ff7 > Record changed: 2026-10-13 # A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years NCT07413666 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) Participants 212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) Lead sponsor Centessa Pharmaceuticals (UK) Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) Start date 2026-02-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## Title and summary **Summary** Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Short title** A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Official title** A Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## Dates **Completion date** 2027-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **First posted** 2026-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Registry last updated** 2026-02-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Primary completion date** 2027-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Start date** 2026-02-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## Size and sites **Participants** 212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Planned participants** 212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Lead sponsor** Centessa Pharmaceuticals (UK) Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## Identifiers **Registry ID** NCT07413666 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **ClinicalTrials.gov ID** NCT07413666 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## 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/NCT07413666) ## Outcomes ### Primary outcomes 1. Part A Timeframe: From enrollment to the Follow-Up Visit 7 days post-discharge 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. 2. Part B Timeframe: From enrollment to the Follow-Up Visit 7 days post-discharge\] 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 3. Part C Timeframe: From enrollment to the Follow-Up Visit 7 days post-discharge\] 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 4. Part D: Timeframe: From enrollment to the Follow-Up Visit 7 days post-discharge 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 ### Secondary outcomes 1. Cmax Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489 2. Tmax Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours Time of Maximum Concentration for ORX489 in participants receiving ORX489 3. AUClast Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for ORX489 in participants receiving ORX489 4. T 1/2 (terminal elimination half-life) Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours The time required for the terminal phase blood concentration of ORX489 to decrease by half in participants receiving ORX489 5. Cmax Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489 in the fasted and fed state. 6. Tmax Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours Time of Maximum Concentration for ORX489 in participants receiving ORX489 in the fast and fed state 7. AUClast Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for ORX489 in participants receiving ORX489 in the fast and fed state 8. T 1/2 (terminal elimination half-life) Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours The time required for the terminal phase blood concentration of ORX489 to decrease by half in participants receiving ORX489 in the fast and fed state 9. Mean sleep latency in the Maintenance of Wakefulness Test (MWT) Timeframe: Part D: Day 1-2 Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX489 versus placebo: MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake 10. Karolinska Sleepiness Scale score Timeframe: Part D: Day 1-2 Karolinska Sleepiness Scale score for ORX489 versus placebo: 9-point scale, ranging from "extremely alert" (1) to "very sleepy, great effort keeping awake, fighting sleep Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### Inclusion criteria - 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 ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## Sites - CelerionLincoln, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07413666) ## 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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