Narcolepsy, Excessive Daytime SleepinessPhase 1NCT02215499
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
A Phase 1 study testing Sodium Oxybate and JZP-386 in people with Narcolepsy, Excessive Daytime Sleepiness, run by Concert Pharmaceuticals at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy, Excessive Daytime Sleepiness
- What is being tested?
- Sodium Oxybate and JZP-386
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical Ltd.
Ruddington, Nottingham, NG11 6JS
About this study
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
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.
Read the 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 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).
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness
- Being tested
- Placebo, Sodium Oxybate, JZP-386
- Keywords
- JZP-386, Xyrem, sodium oxybate
- Medical subject headings
- Narcolepsy, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Sodium OxybateDrug
Also called Xyrem®
JZP-386Drug
| Study group | Role | What they receive |
|---|---|---|
| Xyrem® | Active comparator | Oral suspension Receives: Drug: Placebo; Drug: Sodium Oxybate |
| JZP-386 | Experimental | Oral suspension Receives: Drug: Placebo; Drug: JZP-386 |
| Placebo | Placebo comparator | Oral suspension Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (1)
pharmacokinetics
Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy, Excessive Daytime SleepinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LuAnn Sabounjian, Study director, Concert Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215499
- Sponsor's protocol ID
- CP386.1001
- Status last verified
- May 2015
- First submitted
- 8 Aug 2014
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02215499
- Acronym / sponsor ID
- CP386.1001
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness
- Keywords
- JZP-386, Xyrem, sodium oxybate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xyrem® | Active comparator | Drug: Placebo, Drug: Sodium OxybateOral suspension |
| JZP-386 | Experimental | Drug: Placebo, Drug: JZP-386Oral suspension |
| Placebo | Placebo comparator | Drug: PlaceboOral suspension |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Drug | JZP-386, Placebo, Xyrem® |
| Sodium OxybateAlso: Xyrem® | Drug | Xyrem® |
| JZP-386 | Drug | JZP-386 |
Primary outcome
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.
1 secondary outcome
pharmacokinetics
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LuAnn Sabounjian study director
Concert Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Oxybate and JZP-386 in people with Narcolepsy, Excessive Daytime Sleepiness, run by Concert Pharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.