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

What this study is

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

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
Sponsor: Centessa Pharmaceuticals (UK) Limited
Conditions: Excessive Daytime Sleepiness
Enrolling: 208 people
Starts: 2025-06-30
Est. completion: 2026-06-15
Design: Double-blind, randomized, parallel groups, Phase 1
Record: View on ClinicalTrials.gov ↗

Age 18 Years – 80 YearsSex ALLHealthy volunteers Accepted

You may qualify if

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

You can't join if

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.

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1

3 open

Sponsor

Study ID ORX142-0101

CONTACT

Have questions? The contacts above can answer them before you apply.

The sponsor hasn't published answers to common questions for this trial.