RECRUITING

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

Conditions

Excessive Daytime Sleepiness orexin-2 receptor agonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-06-30

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07082829

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

ORX142 Centessa Program Lead

CONTACT

617-468-5770

ORX142-0101study@centessa.com

Study Locations (Sites)

Site #1

Lincoln, Nebraska, 68502

United States

Collaborators and Investigators

Sponsor: Centessa Pharmaceuticals (UK) Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-06-30

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Excessive Daytime Sleepiness
orexin-2 receptor agonist

Additional Relevant MeSH Terms

Excessive Daytime Sleepiness