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

NCT02215499 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-05-29

No results posted yet for this study

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.

Conditions

  • Narcolepsy, Excessive Daytime Sleepiness

Interventions

DRUG

JZP-386

DRUG

Placebo

DRUG

Sodium Oxybate

Sponsors & Collaborators

  • Concert Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • LuAnn Sabounjian · Concert Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02215499 on ClinicalTrials.gov