Back to resultsA Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
Primary Purpose
Narcolepsy, Excessive Daytime Sleepiness
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Sodium Oxybate
JZP-386
Sponsored by
About this trial
This is an interventional basic science trial for Narcolepsy, Excessive Daytime Sleepiness focused on measuring JZP-386, Xyrem, sodium oxybate
Eligibility 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.
Sites / Locations
- Quotient Clinical Ltd.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Xyrem®
JZP-386
Placebo
Arm Description
Oral suspension
Oral suspension
Oral suspension
Outcomes
Primary Outcome Measures
safety
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
pharmacokinetics
Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02215499
Brief Title
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concert Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy, Excessive Daytime Sleepiness
Keywords
JZP-386, Xyrem, sodium oxybate
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xyrem®
Arm Type
Active Comparator
Arm Description
Oral suspension
Arm Title
JZP-386
Arm Type
Experimental
Arm Description
Oral suspension
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral suspension
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate
Other Intervention Name(s)
Xyrem®
Intervention Type
Drug
Intervention Name(s)
JZP-386
Primary Outcome Measure Information:
Title
safety
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
pharmacokinetics
Description
Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LuAnn Sabounjian
Organizational Affiliation
Concert Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Quotient Clinical Ltd.
City
Ruddington
State/Province
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
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