An Open-Label, Randomized, Crossover Pilot Study to Evaluate the Pharmacokinetics and Relative Bioavailability of JZP-324 Formulations vs. Xyrem in Healthy Subjects
- Conditions
- narcolepsysleeping disorder10040998
- Registration Number
- NL-OMON48951
- Lead Sponsor
- Jazz Pharmaceuticals, inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
- healthy male or female
- between 18 and 45 years of age, inclusive
- BMI between 20 and 30 kg/m2, inclusive, with a body weight at least 60 kilograms
- Has a clinically significant unstable medical abnormality, chronic disease, or history or presence of significant neurological (including seizure and cognitive disorders) or psychiatric disorder, hepatic, renal, endocrine, cardiovascular (including hypertension), gastrointestinal, pulmonary, or metabolic disease or any other abnormality that could interfere with the pharmacokinetic evaluation of the study drug.
- Has a history or the presence of gastrointestinal (including peptic ulcer), hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Is a female subject who is pregnant, nursing, or lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1:<br /><br>To assess the pharmacokinetics (PK) and relative bioavailability of the JZP-324<br /><br>formulation components compared with Xyrem when dosed 2 hours after the start<br /><br>of a high-fat, high-calorie breakfast<br /><br><br /><br>Part 2:<br /><br>To evaluate the PK profiles of 4 different IR:MR formulations when dosed at 2<br /><br>hours after the start of a high-fat, high-calorie breakfast.<br /><br><br /><br>Part 3:<br /><br>The primary objective of Part 3 of this study is to evaluate the PK and dose<br /><br>proportionality of the IR:DR3 formulation, which was selected based on the data<br /><br>generated from Part 2.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1, 2 and 3:<br /><br>To assess the safety and tolerability of the JZP-324 formulations and Xyrem<br /><br>when dosed 2 hours after the start of a high-fat, high-calorie breakfast</p><br>