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 developed by Jazz Pharmaceuticals plc. It is being studied in Phase 1 clinical trials in healthy participants, including sleep-deprived healthy volunteers. No approved indication has been disclosed for JZP441.
JZP441 targets the orexin-2 receptor, a receptor in the orexin signaling system. Orexin-2 receptor activity is associated with regulation of sleep and wakefulness. JZP441 is a small molecule designed to interact with this receptor, and it is being evaluated in early-stage clinical studies.
JZP441 is being developed by Jazz Pharmaceuticals plc, which trades on the Nasdaq under the ticker JAZZ. Jazz Pharmaceuticals is the sponsor of the clinical trials evaluating JZP441 in healthy participants.
JZP441 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Two Phase 1 trials of JZP441 have been completed, and no active trials are currently listed.
JZP441 has been studied in two completed Phase 1 trials. NCT05720494 was a multiple ascending dose study in healthy participants with 24 enrolled. NCT05651152 evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in sleep-deprived healthy participants with 105 enrolled. Both were conducted in the United States.
Both JZP441 Phase 1 trials were randomized, double-blind, and placebo-controlled, enrolling a total of 129 healthy participants aged 18 years and older in the United States. One trial used a multiple ascending dose design, and the other assessed sleep-deprived healthy participants.