A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 8, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMay 29, 2015
May 1, 2015
4 months
August 8, 2014
May 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 days
Secondary Outcomes (1)
pharmacokinetics
12 hours
Study Arms (3)
Xyrem®
ACTIVE COMPARATOROral suspension
JZP-386
EXPERIMENTALOral suspension
Placebo
PLACEBO COMPARATOROral suspension
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Clinical Ltd.
Ruddington, Nottingham, NG11 6JS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
LuAnn Sabounjian
Concert Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2014
First Posted
August 13, 2014
Study Start
July 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
May 29, 2015
Record last verified: 2015-05