Healthy Participants Clinical Trial
Official title:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Nighttime Doses of JZP441 in Sleep-Deprived Healthy Participants: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study
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. ;
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