Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JZP441 · 2 trials · 1 indication
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...
JZP441 is an investigational small molecule being studied in healthy participants. It is being evaluated in Phase 1 clinical trials to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics, including in sleep-deprived healthy participants. It is not approved for any indication and remains in clinical development.
JZP441 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on NASDAQ under the ticker JAZZ. The company is conducting Phase 1 clinical trials of JZP441 in healthy participants in the United States.
JZP441 is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving healthy participants. The drug is investigational and has not been approved by regulatory authorities. Its safety and tolerability are being evaluated in these early-stage trials.
JZP441 has been studied in two completed Phase 1 clinical trials. NCT05651152 investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of JZP441 in sleep-deprived healthy participants with 105 enrolled. NCT05720494 was a multiple ascending dose study in healthy participants with 24 enrolled. Both were conducted in the United States.
JZP441 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials have evaluated its safety, tolerability, and pharmacokinetics in healthy participants, but it has not received marketing approval for any use.