BioavailabilityNCT02138396
Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions
A study testing Fentanyl Sublingual Spray (FSS), Fentanyl Citrate Injection (FCI) and Naltrexone in people with Bioavailability, run by INSYS Therapeutics Inc at 1 site in United States.
Trial summary
The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Fentanyl Sublingual Spray (FSS), Fentanyl Citrate Injection (FCI) and Naltrexone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2014
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets protocol-specified criteria for qualification and contraception
- Good access to veins on both sides
- 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
- Intolerance to venipuncture or injections
- Presence or history of oral disease, irritation or piercings
- Allergy or adverse response to fentanyl, naltrexone, or related drugs
- Tattoos, scarring, or other skin abnormality at planned injection sites
- History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) 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: Single-Dose, Open-Label, Two-Period, Two-Treatment, Two-Sequence Crossover Exploratory Bioavailability Study of Subsys® (Fentanyl Sublingual Spray), 400 mcg, and Fentanyl Citrate Injection 2 mL x 0.05 mg/mL (Total Dose 100 mcg) Under Fasted Conditions
The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.
- Conditions
- Bioavailability
- Being tested
- Fentanyl Sublingual Spray (FSS), Fentanyl Citrate Injection (FCI), Naltrexone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Sublingual Spray (FSS)Drug
Also called Subsys®
A single dose of fentanyl, 400 mcg per sublingual spray
Fentanyl Citrate Injection (FCI)Drug
A single dose of fentanyl citrate, 100 mcg per intramuscular injection
NaltrexoneDrug
Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.
| Study group | Role | What they receive |
|---|---|---|
| FSS first, then FCI | Experimental | At each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single dose of fentanyl sublingual spray (FSS) at the first visit. After a washout period of at least seven days, they receive a single intramuscular fentanyl citrate injection (FCI) at the second treatment visit. Receives: Drug: Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate Injection (FCI); Drug: Naltrexone |
| FCI first, then FSS | Experimental | At each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single intramuscular fentanyl citrate injection (FCI) at the first visit. After a washout period of at least seven days, they receive a single dose of fentanyl sublingual spray (FSS) at the second treatment visit. Receives: Drug: Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate Injection (FCI); Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) by mode of administration
Measured: within 36 hours after dosing
Secondary outcomes (2)
Area under the concentration-time curve [AUC(last)] by mode of administration
Measured: prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose
Area under the curve extrapolated to infinity [AUC(inf)] by mode of administration
Measured: prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George J Atiee, MD, Principal investigator, Worldwide Clinical Trials Early Phase Services, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138396
- Sponsor's protocol ID
- INS-13-019
- Status last verified
- Dec 2014
- First submitted
- 12 May 2014
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose, Open-Label, Two-Period, Two-Treatment, Two-Sequence Crossover Exploratory Bioavailability Study of Subsys® (Fentanyl Sublingual Spray), 400 mcg, and Fentanyl Citrate Injection 2 mL x 0.05 mg/mL (Total Dose 100 mcg) Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT02138396
- Acronym / sponsor ID
- INS-13-019
- Conditions
- Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 May 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.
The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSS first, then FCI | Experimental | Drug: Fentanyl Sublingual Spray (FSS), Drug: Fentanyl Citrate Injection (FCI), Drug: NaltrexoneAt each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single dose of fentanyl sublingual spray (FSS) at the first visit. After a washout period of at least seven days, they receive a single intramuscular fentanyl citrate injection (FCI) at the second treatment visit. |
| FCI first, then FSS | Experimental | Drug: Fentanyl Sublingual Spray (FSS), Drug: Fentanyl Citrate Injection (FCI), Drug: NaltrexoneAt each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single intramuscular fentanyl citrate injection (FCI) at the first visit. After a washout period of at least seven days, they receive a single dose of fentanyl sublingual spray (FSS) at the second treatment visit. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets protocol-specified criteria for qualification and contraception
- Good access to veins on both sides
- 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 (6 listed)
- Intolerance to venipuncture or injections
- Presence or history of oral disease, irritation or piercings
- Allergy or adverse response to fentanyl, naltrexone, or related drugs
- Tattoos, scarring, or other skin abnormality at planned injection sites
- History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
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 |
|---|---|---|
| Fentanyl Sublingual Spray (FSS)Also: Subsys®A single dose of fentanyl, 400 mcg per sublingual spray | Drug | FCI first, then FSS, FSS first, then FCI |
| Fentanyl Citrate Injection (FCI)A single dose of fentanyl citrate, 100 mcg per intramuscular injection | Drug | FCI first, then FSS, FSS first, then FCI |
| NaltrexoneNaltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl. | Drug | FCI first, then FSS, FSS first, then FCI |
Primary outcome
Maximum concentration (Cmax) by mode of administration
Time frame: within 36 hours after dosing
2 secondary outcomes
Area under the concentration-time curve [AUC(last)] by mode of administration
Time frame: prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose
Area under the curve extrapolated to infinity [AUC(inf)] by mode of administration
Time frame: prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose
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 12 Dec 2014.
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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.
George J Atiee, MD principal investigator
Worldwide Clinical Trials Early Phase Services, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl Sublingual Spray (FSS), Fentanyl Citrate Injection (FCI) and Naltrexone in people with Bioavailability, 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 4 inclusion and 6 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 12 Dec 2014. 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.
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 concentration (Cmax) by mode of administration (time frame: within 36 hours after dosing). 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 12 Dec 2014.