Status:
COMPLETED
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Narcolepsy, Excessive Daytime Sleepiness
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 dos...
Eligibility Criteria
Inclusion
- Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02215499
Start Date
July 1 2014
End Date
November 1 2014
Last Update
May 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quotient Clinical Ltd.
Ruddington, Nottingham, United Kingdom, NG11 6JS