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Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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: Evaluation of a Single Dose in Healthy Older Adults | Experimental |
| |
| Part E: PoC Study in Acutely Sleep-deprived Healthy Adults | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORX142 Tablets | Drug | ORX142 Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects | Safety and Tolerability as assessed by AEs and SAEs | From enrollment to the Follow-Up Visit 13 days post-discharge |
| Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states | Safety and Tolerability as assessed by AEs and SAEs | From enrollment to the Follow-Up Visit 13 days post-discharge |
| Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects | Safety and Tolerability as assessed by AEs and SAEs | From enrollment to the Follow-Up Visit 13 days post-discharge |
| Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects | Safety and Tolerability as assessed by AEs and SAEs | From enrollment to the Follow-Up Visit 13 days post-discharge |
| 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 | Safety and Tolerability as assessed by AEs and SAEs | From enrollment to the Follow-Up Visit 13 days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ORX142 Centessa Program Lead | Contact | 617-468-5770 | ORX142-0101study@centessa.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #1 | Recruiting | Lincoln | Nebraska | 68502 | United States | |
| Site #2 |
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| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Double-blind (investigator- and subject-blinded)
| Placebo Tablets | Other | Placebo Tablets |
|
| 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 |
| 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 |
| 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 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 |
| Karolinska Sleepiness Scale score for ORX142 versus placebo | Part E: Day 1-2 |
| Recruiting |
| Eatontown |
| New Jersey |
| 07724 |
| United States |
| Site #3 | Recruiting | New York | New York | 10019 | United States |
| D001523 |
| Mental Disorders |