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Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | SAD Study in Healthy Adults: ORX489 and Placebo |
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| Part B | Experimental | Food-effect Evaluation in Healthy Adults: ORX489 |
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| Part C | Experimental | MAD Study in Healthy Adults: ORX489 and Placebo |
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| Part D | Experimental | SAD Study in Acutely Sleep-Deprived Healthy Adults: ORX489 and Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORX489 Tablets | Drug | ORX489 Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A | Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in healthy adult participants. | From enrollment to the Follow-Up Visit 7 days post-discharge |
| Part B | Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in the fasted and fed states | From enrollment to the Follow-Up Visit 7 days post-discharge] |
| Part C | Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by AEs and SAEs of oral multiple ascending doses of ORX489 in healthy adult participants | From enrollment to the Follow-Up Visit 7 days post-discharge] |
| Part D: | Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by AEs and SAEs of oral single oral doses of ORX489 in sleep-deprived healthy adult participants | From enrollment to the Follow-Up Visit 7 days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489 | Pre-dose and multiple post-dose timepoints, up to 48 hours |
| Tmax | Time of Maximum Concentration for ORX489 in participants receiving ORX489 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ORX489 Centessa Program Lead ORX489 Centessa Program Lead | Contact | 617-468-5770 | ORX489-101study@centessa.com | |
| Celerion Program Lead CA49982 United States, Nebraska [Recruiting] | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Recruiting | Lincoln | Nebraska | 68502 | United States |
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Double-blind (investigator- and subject-blinded)
| Placebo Tablets | Other | Placebo Tablets |
|
| 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 ORX489 in participants receiving ORX489 | 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 ORX489 to decrease by half in participants receiving ORX489 | Pre-dose and multiple post-dose timepoints, up to 48 hours |
| Cmax | Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489 in the fasted and fed state. | Pre-dose and multiple post-dose timepoints, up to 48 hours |
| Tmax | Time of Maximum Concentration for ORX489 in participants receiving ORX489 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 ORX489 in participants receiving ORX489 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 ORX489 to decrease by half in participants receiving ORX489 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) | Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX489 versus placebo: MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake | Part D: Day 1-2 |
| Karolinska Sleepiness Scale score | Karolinska Sleepiness Scale score for ORX489 versus placebo: 9-point scale, ranging from "extremely alert" (1) to "very sleepy, great effort keeping awake, fighting sleep | Part D: Day 1-2 |