A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years
Purpose
Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
Condition
- Healthy Adult Male and Female Volunteers
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Key Inclusion Criteria: 1. Healthy males or females as determined by assessments at the Screening Visit. 1. For Parts A, B, C, and D: 2. a. Participants must be at least 18 years of age and no more than 60 years of age at the Screening
Exclusion Criteria
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Double-blind (investigator- and subject-blinded)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A |
SAD Study in Healthy Adults |
|
|
Experimental Part B |
Food-effect Evaluation in Healthy Adults |
|
|
Experimental Part C |
MAD Study in Healthy Adults |
|
|
Experimental Part D |
SAD Study in Acutely Sleep-Deprived Healthy Adults |
|
Recruiting Locations
Celerion
Lincoln 5072006, Nebraska 5073708 68502
Lincoln 5072006, Nebraska 5073708 68502
More Details
- Status
- Recruiting
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Study Contact
ORX489 Centessa Program Lead ORX489 Centessa Program Lead617-468-5770
ORX489-101study@centessa.com