NCT02215499

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Narcolepsy, Excessive Daytime Sleepiness

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	Sodium Oxybate
DRUG	JZP-386

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-08-13
• Last updated: 2015-05-29

Locations

1 site across 1 country: United Kingdom