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

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ClinicalTrials.gov Identifier: NCT02215499
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Narcolepsy, Excessive Daytime Sleepiness Drug: Placebo Drug: Sodium Oxybate Drug: JZP-386 Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : July 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arm Intervention/treatment
Active Comparator: Xyrem®
Oral suspension
Drug: Placebo
Drug: Sodium Oxybate
Other Name: Xyrem®

Experimental: JZP-386
Oral suspension
Drug: Placebo
Drug: JZP-386
Placebo Comparator: Placebo
Oral suspension
Drug: Placebo



Primary Outcome Measures :
  1. safety [ Time Frame: 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 :
  1. pharmacokinetics [ Time Frame: 12 hours ]
    Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215499


Locations
United Kingdom
Quotient Clinical Ltd.
Ruddington, Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Concert Pharmaceuticals
Investigators
Study Director: LuAnn Sabounjian Concert Pharmaceuticals

Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02215499     History of Changes
Other Study ID Numbers: CP386.1001
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Concert Pharmaceuticals:
JZP-386, Xyrem, sodium oxybate

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs