Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05720494 | A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants | PHASE1 | COMPLETED | 24 | — | — | Jan 26, 2023 | Sep 29, 2023 | Oct 1, 2024 | 1 | United States |
| NCT05651152 | A Study to Investigate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP441 in Sleep-deprived Healthy Participants | PHASE1 | COMPLETED | 105 | — | — | Nov 28, 2022 | Nov 15, 2023 | Jul 30, 2024 | 2 | United States |
Time to maximum plasma concentration (Tmax), time of maximum observed plasma concentration post first dose but before second dose during the 24-hour dosing interval (Tmax1), and time of maximum observed plasma concentration post second dose during the 24-hour dosing interval (Tmax2), and time of last quantifiable concentration (Tlast) will be assessed.
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24), area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC0-last), and area under the concentration-time curve from time zero extrapolated to infinity (AUC∞) will be assessed.
Accumulation ratio (Cmax) and accumulation ratio (AUC) will be assessed.
Dose proportionality of maximum concentration (Cmax), maximum observed plasma concentration post first dose but before second dose during the 24-hour dosing interval (Cmax1), and maximum observed plasma concentration post second dose during the 24-hour dosing interval (Cmax2) will be assessed.
Dose proportionality of area under the concentration-time curve from 0 to 24 hours (AUC\[0-24\]) will be assessed.
| Arm | Type | Description |
|---|---|---|
| JZP441 | EXPERIMENTAL | Healthy participants who will be randomized to receive an oral dose of JZP441. |
| Placebo | PLACEBO_COMPARATOR | Healthy participants who will be randomized to receive placebo. |
| Name | Type | Description |
|---|---|---|
| JZP441 | DRUG | Oral study drug administered for up to 4 weeks |
| Placebo | DRUG | Oral placebo administered for up to 4 weeks |
Inclusion Criteria: * Is 18 to 50 years of age inclusive, at the time of signing the informed consent * Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac/blood pressure monitoring. Exclusion Criteria: * History or pres...