A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics

Study Overview
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Brief Summary
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This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.

Detailed Description
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This is a Phase 1, single center, single-ascending dose, sequential, randomized, and crossover study. Following a Screening period of up to 21 days, eligible subjects will be randomized different dosing sequences, with approximately 4 subjects allocated to each dosing sequence. The total in-clinic duration for each subject will be 24 days (including the admission day prior to the first dosing period).

Official Title
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A Double-Blind, Phase 1, Single-Center, Single-Ascending Dose Study of JZP-386 Compared to Xyrem® vs. Placebo to Evaluate the Safety and Pharmacokinetics

Conditions
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Narcolepsy, Excessive Daytime Sleepiness

Intervention / Treatment
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* Drug: Placebo
* Drug: Sodium Oxybate
* Drug: JZP-386


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive. Exclusion Criteria: Clinically significant history of unstable medical abnormality. Inability to cooperate with study procedures. Female subjects with a positive pregnancy test result, nursing or lactating. Participation in any other investigational drug trial within 90 days prior to screening. A history of prescription drug abuse, or illicit drug or known drug dependence within last 5 years prior to screening. Use of any prescription medication within 14 days prior to dosing. A history of alcohol abuse or dependence.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xyrem®<br>Oral suspension | Drug: Placebo<br> <br> Drug: Sodium Oxybate<br> <br> * Other names: Xyrem®;|
| Experimental: JZP-386<br>Oral suspension | Drug: Placebo<br> <br> Drug: JZP-386<br> <br> |
| Placebo Comparator: Placebo<br>Oral suspension | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | Evaluate and compare the safety including adverse event monitoring (number and type of events), vital signs, pulse oximetry of single ascending doses of JZP-386 to Xyrem (sodium oxybate) and placebo in healthy subjects. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics | Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects. | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JZP-386, Xyrem, sodium oxybate