NCT07082829PHASE1RecruitingAccepts Healthy Volunteers
A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
Centessa Pharmaceuticals (UK) Limited
Start Date
6/30/2025
Completion Date
6/15/2026
Summary
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
Eligibility Criteria
Age Range: 18 years to 80 years
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.
Interventions
DRUG
ORX142 Tablets
OTHER
Placebo Tablets
Conditions
Excessive Daytime Sleepiness
Locations
Site #1
Lincoln, Nebraska 68502
United States
Site #2
Eatontown, New Jersey 07724
United States
Site #3
New York, New York 10019
United States