An Open-Label, Randomized, Crossover Pilot Study to Evaluate the Pharmacokinetics and Relative Bioavailability of JZP-324 Formulations vs. Xyrem in Healthy Subjects

An Open-Label, Randomized, Crossover Pilot Study to Evaluate the Pharmacokinetics and Relative Bioavailability of JZP-324 Formulations vs. Xyrem in Healthy Subjects - JZP 324 BA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48951

Enrollment

Registered

2017-09-27

Start date

2017-09-28

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

narcolepsy sleeping disorder

Interventions

Part 1: In this study, the volunteer will receive a total of 6 treatments of study compound. During the study the volunteer will receive 5 JZP-324 treatments and 1 Xyrem treatment every other day fo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Part 1: To assess the pharmacokinetics (PK) and relative bioavailability of the JZP-324 formulation components compared with Xyrem when dosed 2 hours after the start of a high-fat, high-calorie breakfast Part 2: To evaluate the PK profiles of 4 different IR:MR formulations when dosed at 2 hours after the start of a high-fat, high-calorie breakfast. Part 3: The primary objective of Part 3 of this study is to evaluate the PK and dose proportionality of the IR:DR3 formulation, which was selected based on the data generated from Part 2.	—

Measure

Time frame

Part 1: To assess the pharmacokinetics (PK) and relative bioavailability of the JZP-324 formulation components compared with Xyrem when dosed 2 hours after the start of a high-fat, high-calorie breakfast Part 2: To evaluate the PK profiles of 4 different IR:MR formulations when dosed at 2 hours after the start of a high-fat, high-calorie breakfast. Part 3: The primary objective of Part 3 of this study is to evaluate the PK and dose proportionality of the IR:DR3 formulation, which was selected based on the data generated from Part 2.

—

Secondary

Measure	Time frame
Part 1, 2 and 3: To assess the safety and tolerability of the JZP-324 formulations and Xyrem when dosed 2 hours after the start of a high-fat, high-calorie breakfast	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)