A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
Not Applicable
Recruiting
- Conditions
- Excessive Daytime Sleepiness
- Interventions
- Drug: ORX142 TabletsOther: Placebo Tablets
- Registration Number
- NCT07082829
- Lead Sponsor
- Centessa Pharmaceuticals (UK) Limited
- Brief Summary
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 208
Inclusion Criteria
-
Healthy males or females as determined by assessments at the Screening Visit.
For Parts A, B, C, and D:
a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening
-
For Part E:
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: SAD Study in Healthy Adults ORX142 Tablets - Part A: SAD Study in Healthy Adults Placebo Tablets - Part B: Food-effect Evaluation in Healthy Adults ORX142 Tablets - Part C: MAD Study in Healthy Adults ORX142 Tablets - Part D: Evaluation of a Single Dose in Healthy Older Adults Placebo Tablets - Part C: MAD Study in Healthy Adults Placebo Tablets - Part D: Evaluation of a Single Dose in Healthy Older Adults ORX142 Tablets - Part E: PoC Study in Acutely Sleep-deprived Healthy Adults ORX142 Tablets - Part E: PoC Study in Acutely Sleep-deprived Healthy Adults Placebo Tablets -
- Primary Outcome Measures
Name Time Method Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects From enrollment to the Follow-Up Visit 7 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 From enrollment to the Follow-Up Visit 7 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 From enrollment to the Follow-Up Visit 7 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 From enrollment to the Follow-Up Visit 7 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 From enrollment to the Follow-Up Visit 7 days post-discharge Safety and Tolerability as assessed by AEs and SAEs
- Secondary Outcome Measures
Name Time Method Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 Pre-dose and multiple post-dose timepoints, up to 48 hours Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 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 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 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 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 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 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. Part E: Day 2 Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 in the fasted and fed state. Pre-dose and multiple post-dose timepoints, up to 48 hours Karolinska Sleepiness Scale score for ORX142 versus placebo Part E: Day 1-2
Trial Locations
- Locations (1)
Site #1
🇺🇸Lincoln, Nebraska, United States
Site #1🇺🇸Lincoln, Nebraska, United States