RecruitingPhase 1NCT07082829

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


Sponsor

Centessa Pharmaceuticals (UK) Limited

Enrollment

208 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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

Exclusion Criteria3

  • 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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Interventions

DRUGORX142 Tablets

ORX142 Tablets

OTHERPlacebo Tablets

Placebo Tablets


Locations(3)

Site #1

Lincoln, Nebraska, United States

Site #2

Eatontown, New Jersey, United States

Site #3

New York, New York, United States

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NCT07082829


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