A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
- Summary
- Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
- Short title
- A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-06-15
- First posted
- 2025-07-24
- Registry last updated
- 2025-12-24
- Primary completion date
- 2026-06-15
- Start date
- 2025-06-30
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Centessa Pharmaceuticals (UK) Limited
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07082829
- ClinicalTrials.gov ID
- NCT07082829
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masking description
- Double-blind (investigator- and subject-blinded)
- Masked roles
- Participants, Investigators
Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects
Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states
Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects
Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects
Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part E: Incidence and severity of Treatment-Emergent Adverse Events of oral of single oral doses of ORX142 in acutely sleep-deprived healthy adult subjects
Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 in the fasted and fed state.
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142 in the fast and fed state
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX142 versus placebo.
Timeframe: Part E: Day 2
Karolinska Sleepiness Scale score for ORX142 versus placebo
Timeframe: Part E: Day 1-2
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- Yes
Key Inclusion Criteria:
-
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
-
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:
- 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.
- History of seizure disorder, any other condition that increases the risk of seizure
- Has a clinically significant sleep disorder, including insomnia or sleep apnea.
- Site #1Lincoln, United StatesRecruiting
- Site #2Eatontown, United StatesRecruiting
- Site #3New York, United StatesRecruiting