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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
3
Research Sites
N/A
Total Duration
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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 drug's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 13 days from enrollment to follow-up
Participants receive single or multiple doses of ORX142 or placebo in various parts of the study including in healthy adults, older adults, and acutely sleep-deprived adults.
Multiple visits including dosing and assessments up to 13 days post-discharge
Duration - 13 days post-discharge
Participants are monitored for safety and tolerability after receiving the study drug, including assessment of adverse events and pharmacokinetics.
Follow-up visits up to 13 days after discharge
Trial Site Locations
Total: 3 locations
1
Site #1
Lincoln, Nebraska, United States, 68502
Actively Recruiting
2
Site #2
Eatontown, New Jersey, United States, 07724
Actively Recruiting
3
Site #3
New York, New York, United States, 10019
Actively Recruiting
Research Team
O
ORX142 Centessa Program Lead
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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