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

GHB

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.

Intervention / Treatment

  • Placebo (DRUG)
    N/A
  • Sodium Oxybate (DRUG)
    N/A
  • JZP-386 (DRUG)
    N/A

Condition or Disease

  • Narcolepsy, Excessive Daytime Sleepiness

Phase

  • Phase 1
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 50 Years
    Enrollment: 28 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 01, 2014
    Primary Completion: Nov 01, 2014 ACTUAL
    Completion Date: Nov 01, 2014 ACTUAL
    Study First Posted: Aug 13, 2014 ESTIMATED
    Results First Posted: Aug 30, 2020
    Last Updated: May 28, 2015

    Sponsors / Collaborators

    Lead Sponsor: Concert Pharmaceuticals
    Lead sponsor is responsible party
    Responsible Party: N/A

    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).

    Participant Groups

    • Oral suspension

    • Oral suspension

    • Oral suspension

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 50
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • 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 Outcomes
    • Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.

    More Details

    NCT Number: NCT02215499
    Other IDs: CP386.1001
    Study URL: https://clinicaltrials.gov/study/NCT02215499
    Last updated: Sep 29, 2023