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

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

Who can join

Ages 18 to 80 · All sexes · Healthy volunteers welcome

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.

About the study

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

What is being tested

• ORX142 Tablets (drug)
• Placebo Tablets (other)

Sponsor: Centessa Pharmaceuticals (UK) Limited · Participants: 208 · Started: Jun 30, 2025

Contact the study team

• ORX142 Centessa Program Lead · Phone: 617-468-5770

Official record on ClinicalTrials.gov — NCT07082829

Locations in the U.S.

Conditions

• Disorders of Excessive Somnolence

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.