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

NCT ID: NCT02215499

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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

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Narcolepsy, Excessive Daytime Sleepiness

Keywords

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JZP-386, Xyrem, sodium oxybate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xyrem®

Oral suspension

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Sodium Oxybate

Intervention Type DRUG

JZP-386

Oral suspension

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

JZP-386

Intervention Type DRUG

Placebo

Oral suspension

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

Sodium Oxybate

Intervention Type DRUG

JZP-386

Intervention Type DRUG

Other Intervention Names

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Xyrem®

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Concert Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LuAnn Sabounjian

Role: STUDY_DIRECTOR

Concert Pharmaceuticals

Locations

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Quotient Clinical Ltd.

Ruddington, Nottingham, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CP386.1001

Identifier Type: -

Identifier Source: org_study_id