What is ORX142 studying for excessive daytime sleepiness?

ORX142 is being studied to understand its safety, how well people tolerate it, and how the body processes it in healthy adults. The trial includes testing single and multiple doses, effects of food, and effects in older adults and those who are sleep-deprived. The sponsor is Centessa Pharmaceuticals (UK) Limited.

Who may be eligible for this excessive daytime sleepiness clinical trial?

Adults aged 18 to 55 or 60 to 80 years who are healthy may be eligible. Participants should not have major medical conditions, seizure disorders, or significant sleep disorders like insomnia or sleep apnea. The trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this excessive daytime sleepiness clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 80Years

All Genders

Healthy Volunteers

ID07082829

A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of ORX142 in Healthy Adults Including Older and Sleep-deprived Subjects

Led by Centessa Pharmaceuticals (UK) Limited · Updated on 2025-12-24

208

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes a drug called ORX142 in healthy adults aged 18 to 80 years. This Phase 1 clinical trial includes several parts to study single and multiple doses, the effects of food on the drug, and tests in both younger and older adults, as well as in people who have been acutely sleep-deprived. The study aims to understand the drugs effects on excessive daytime sleepiness. Participants will receive ORX142 or placebo tablets in different parts of the study. Parts A, B, and C focus on single and multiple ascending doses in healthy adults, with Part B examining the food effect on the drug. Part D studies single doses in healthy older adults, while Part E tests the drug in acutely sleep-deprived healthy adults. The study uses a randomized, double-blind, placebo-controlled design. During the trial, participants will be closely monitored for side effects and treatment-emergent adverse events from enrollment until 13 days after discharge. Blood samples will be taken before and after dosing to measure drug levels and how the body processes it over time. Sleepiness will be assessed using tests like the Maintenance of Wakefulness Test and the Karolinska Sleepiness Scale in Part E. Overall participation duration varies depending on the part of the study involved.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Healthy males or females as determined by assessments at the Screening Visit
For Parts A, B, C, and E: Participants must be between 18 and 55 years old at Screening
For Part D: Participants must be between 60 and 80 years old at Screening

You will not qualify if you...

Significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological, or psychiatric disease
History of seizure disorder or any condition increasing seizure risk
Clinically significant sleep disorders, including insomnia or sleep apnea

Research Team

ORX142 Centessa Program Lead

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