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.
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
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.
Condition or Disease
- Narcolepsy, Excessive Daytime Sleepiness
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 50 Years |
| Enrollment: | 28 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | Randomized |
| Primary Purpose: | Basic Science |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Jul 01, 2014 | |
|---|---|---|
| Primary Completion: | Nov 01, 2014 | ACTUAL |
| Completion Date: | Nov 01, 2014 | ACTUAL |
| Study First Posted: | Aug 13, 2014 | ESTIMATED |
| Results First Posted: | Aug 30, 2020 | |
| Last Updated: | May 28, 2015 |
Sponsors / Collaborators
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).
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).
Participant Groups
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Oral suspension
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Oral suspension
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Oral suspension
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 50 |
| Age Groups: | Adult |
| Healthy Volunteers: | Yes |
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.
* 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.
Primary Outcomes
Secondary Outcomes
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Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.
More Details
| NCT Number: | NCT02215499 |
|---|---|
| Other IDs: | CP386.1001 |
| Study URL: | https://clinicaltrials.gov/study/NCT02215499 |
Last updated: Sep 29, 2023