A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
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|ClinicalTrials.gov Identifier: NCT02215499|
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy, Excessive Daytime Sleepiness||Drug: Placebo Drug: Sodium Oxybate Drug: JZP-386||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|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 Start Date :||July 2014|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
Active Comparator: Xyrem®
Drug: Sodium Oxybate
Other Name: Xyrem®
|Drug: Placebo Drug: JZP-386|
Placebo Comparator: Placebo
- safety [ Time Frame: 3 days ]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.
- pharmacokinetics [ Time Frame: 12 hours ]Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215499
|Quotient Clinical Ltd.|
|Ruddington, Nottingham, United Kingdom, NG11 6JS|
|Study Director:||LuAnn Sabounjian||Concert Pharmaceuticals|