This Phase 1, double-blind, randomized, placebo-controlled study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ascending nighttime doses of JZP441 in sleep-deprived healthy participants.
This study will initially employ nighttime dosing in sleep-deprived healthy participants. Participants (up to 12 per cohort) will be randomized to study intervention. Participants will remain awake during the day and then will be dosed at night. Safety, tolerability, PK and PD assessments will be conducted for nighttime dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
Clinical Site 1
Eatontown, New Jersey, United States
Clinical Site 2
New York, New York, United States
Number of Participants With Treatment-emergent Adverse Events After Administration of JZP441 in Sleep-deprived Healthy Participants
Time frame: 1 hour postdose up to Day 8
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to 36 hours
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to 36 hours
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to 36 hours
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