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

Phase 1

Completed

• Conditions: Narcolepsy, Excessive Daytime Sleepiness
• Interventions: Drug: Placebo; Drug: Sodium Oxybate; Drug: JZP-386

• Registration Number: NCT02215499
• Lead Sponsor: Concert Pharmaceuticals

Brief Summary

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

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).

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-13
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Xyrem®	Placebo	Oral suspension
Xyrem®	Sodium Oxybate	Oral suspension
JZP-386	Placebo	Oral suspension
JZP-386	JZP-386	Oral suspension
Placebo	Placebo	Oral suspension

Primary Outcome Measures

Name	Time	Method
safety	3 days	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.

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics	12 hours	Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.

Trial Locations

Locations (1)

Quotient Clinical Ltd.; 🇬🇧 Ruddington, Nottingham, United Kingdom