Jazz Pharmaceuticals
This study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269 in healthy participants.
This first-in-human study is designed to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269, an orexin-2 receptor agonist, in healthy participants. The study will also assess the effect of food on JZP269 PK, characterize cerebrospinal fluid (CSF) exposure, and evaluate the wake-promoting PD effects using the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS) in sleep-deprived participants.
Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is 18 to 55 years of age, inclusive, at the time of signing the informed consent. 2. Is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac/blood pressure monitoring. 3. Has a body weight of at least 45 kg and BMI within the range of 18.5 to 30 kg/m\^2 (inclusive). Participants are excluded from the study if any of the following criteria apply: 1. Has a history of or presence of clinically significant medical il…
Administered as described.
Administered as described.
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