Overview
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
Status:
Completed
Completed
Trial end date:
2014-11-01
2014-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Concert PharmaceuticalsTreatments:
Sodium Oxybate
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.