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
Centessa Pharmaceuticals (UK) Limited
Summary
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
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 scr…
Interventions
- DrugORX142 Tablets
ORX142 Tablets
- OtherPlacebo Tablets
Placebo Tablets
Locations (3)
- Site #1Lincoln, Nebraska
- Site #2Eatontown, New Jersey
- Site #3New York, New York