RECRUITING

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

Description

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

Conditions

Excessive Daytime Sleepiness
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Related Conditions:

Excessive Daytime Sleepiness

Study Overview

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Study Details

Study overview

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

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

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

Condition
Excessive Daytime Sleepiness
Intervention / Treatment

-

Contacts and Locations

Lincoln

Site #1, Lincoln, Nebraska, United States, 68502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Healthy males or females as determined by assessments at the Screening Visit.
  • 2. For Part E:
  • 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Centessa Pharmaceuticals (UK) Limited,

Study Record Dates

2025-12-31