Opiate DependencePhase 1NCT02477267
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
A Phase 1 study testing SL spray and SL film in people with Opiate Dependence, run by INSYS Therapeutics Inc at 1 site in United States.
Trial summary
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- SL spray and SL film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jul 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Who cannot join
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff;
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- the analysis of results
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, 78217
About this study
Official title: A Pivotal, Phase 1, Open-Label, Randomized, Crossover, Single-Dose, Comparative Bioavailability Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.
- Conditions
- Opiate Dependence
- Being tested
- SL spray, SL film
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL sprayDrug
Also called Buprenorphine naloxone sublingual spray
SL filmDrug
Also called Buprenorphine and naloxone sublingual film
| Study group | Role | What they receive |
|---|---|---|
| Test-Reference Sequence | Experimental | SL spray, followed by SL film Receives: Drug: SL spray; Drug: SL film |
| Reference-Test Sequence | Experimental | SL film followed by SL spray Receives: Drug: SL spray; Drug: SL film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Measured: within 21 days
Time to Cmax (Tmax)
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Measured: within 21 days
Elimination rate constant
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Measured: within 21 days
Elimination half-life (T½)
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Measured: within 21 days
Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast])
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Measured: within 21 days
Area under the curve extrapolated to infinity (AUCinf)
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Measured: within 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies 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
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni DeCastro, Study director, INSYS Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477267
- Sponsor's protocol ID
- INS009-15-033
- Status last verified
- Aug 2015
- First submitted
- 18 Jun 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Phase 1, Open-Label, Randomized, Crossover, Single-Dose, Comparative Bioavailability Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02477267
- Acronym / sponsor ID
- INS009-15-033
- Conditions
- Opiate Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Jun 2015 (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.
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test-Reference Sequence | Experimental | Drug: SL spray, Drug: SL filmSL spray, followed by SL film |
| Reference-Test Sequence | Experimental | Drug: SL spray, Drug: SL filmSL film followed by SL spray |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Key exclusion criteria (5 listed)
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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 |
|---|---|---|
| SL sprayAlso: Buprenorphine naloxone sublingual spray | Drug | Reference-Test Sequence, Test-Reference Sequence |
| SL filmAlso: Buprenorphine and naloxone sublingual film | Drug | Reference-Test Sequence, Test-Reference Sequence |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time to Cmax (Tmax)
Time frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Elimination rate constant
Time frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Elimination half-life (T½)
Time frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast])
Time frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Area under the curve extrapolated to infinity (AUCinf)
Time frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
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 3 Sep 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.
Giovanni DeCastro study director
INSYS Therapeutics Inc
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 SL spray and SL film in people with Opiate Dependence, run by INSYS Therapeutics Inc at 1 site in United States.
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 3 inclusion and 5 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 3 Sep 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 States. 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. 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?
Maximum plasma concentration (Cmax) (time frame: within 21 days). The study lists 6 primary outcomes in all. 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 3 Sep 2015.