PharmacologyPhase 1NCT02641340
Fentanyl Sublingual Spray in Opioid Naive Participants
A Phase 1 study testing Fentanyl Sublingual Spray and Fentanyl Citrate IV in people with Pharmacology, run by INSYS Therapeutics Inc at 1 site in United States.
Trial summary
The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic relationship of multiple dose administration of fentanyl sublingual spray in opioid naive participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacology
- What is being tested?
- Fentanyl Sublingual Spray and Fentanyl Citrate IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets protocol-specified criteria for qualification and contraception
- 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
- 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:
- 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
Lotus Clinical Research, Inc.
Pasadena, California, 91105
About this study
Official title: A Phase 1, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fentanyl Sublingual Spray in Opioid Naive Subjects
The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic relationship of multiple dose administration of fentanyl sublingual spray in opioid naive participants. The secondary objective is to determine the safety and tolerability of multiple dose administration of fentanyl sublingual spray in opioid naive subjects.
Read the detailed description
For all cycles, blood will be drawn according to the following schedule:
The 0 time (pre-dose) blood sample will be collected within 60 minutes prior to first study drug administration.
Cohort l: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2, 4 (prior to second-dose), 4.083, 4.25, 4.5, 5, 6, 8 (prior to third-dose), 8.083, 8.25, 8.5, 9, 10, 12, 16 and 24 hours after the first dose.
Cohort 2: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2 (prior to second-dose), 2.083, 2.25, 2.5, 3, 4 (prior to third-dose), 4.083, 4.25, 4.5, 5, 6, 8, 10, 12, 16 and 24 hours after the first dose.
Cohort 3: 0 (pre-dose), 5, 15, 30 and 45 minutes after the first dose and at 1 (prior to second-dose), 1.083, 1.25, l.5, 1.75, 2 (prior to third-dose), 2.083, 2.25, 2.5, 2.75, 3, 4, 8, 12, 16 and 24 hours after the first dose.
Cohort 4: 0 (pre-dose), 5, 15, 30 (prior to the second-dose), 35, and 45 minutes after the first dose and at I (prior to the third-dose), 1.083, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 4, 8, 12, 16 and 24 hours after the first dose.
- Conditions
- Pharmacology
- Being tested
- Fentanyl Sublingual Spray, Fentanyl Citrate IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Sublingual SprayDrug
Also called SUBSYS®
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Fentanyl Citrate IVDrug
Fentanyl Citrate 50 mcg, delivered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Cycle 1, Cohort 1 | Experimental | Fentanyl Sublingual Spray (FSS) low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every four hours for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 1, Cohort 2 | Experimental | FSS low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every two hours for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 1, Cohort 3 | Experimental | FSS low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every hour for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 1, Cohort 4 | Experimental | FSS low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every 30 minutes for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 2, Cohort 1 | Experimental | FSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every four hours for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 2, Cohort 2 | Experimental | FSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every two hours for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 2, Cohort 3 | Experimental | FSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every hour for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 2, Cohort 4 | Experimental | FSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every 30 minutes for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 3, Cohort 1 | Experimental | FSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every four hours for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 3, Cohort 2 | Experimental | FSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every two hours for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 3, Cohort 3 | Experimental | FSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every hour for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
| Cycle 3, Cohort 4 | Experimental | FSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every 30 minutes for a maximum of three doses. Receives: Drug: Fentanyl Sublingual Spray; Drug: Fentanyl Citrate IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: within 24 hours (see detailed description)
Time to reach peak or maximum concentration following drug administration (Tmax)
Measured: within 24 hours (see detailed description)
Area under the concentration-time curve
Categories: during a dosing interval (AUCtau ), from the time of dosing to infinity (AUC0-inf), from the time of dosing to the last quantifiable time point (AUC0-t)
Measured: within 24 hours (see detailed description)
Apparent elimination rate constant in the terminal phase by non-compartmental analysis
Measured: within 24 hours (see detailed description)
Corresponding half-life (t1/2)
Measured: within 24 hours (see detailed description)
Trough concentration during multiple dosing prior to next dose (Ctrough)
Measured: within 24 hours (see detailed description)
Accumulation ratios
Categories: of Cmax (ARcmax), based on trough concentration (ARctrough), of AUCtau (ARauctau)
Measured: within 24 hours (see detailed description)
Dose normalized Cmax
Measured: within 24 hours (see detailed description)
Dose normalized AUC
Categories: AUC0-1, AUC0-inf, AUCtau
Measured: within 24 hours (see detailed description)
Secondary outcomes (4)
Participants with respiratory depression requiring the use of naloxone
Measured: within 24 hours
Participants with hypoxia requiring oxygen administration
Measured: within 24 hours
Participants needing noninvasive respiratory maneuvers (e.g., jaw thrust, bag-valve mask) to improve respiratory status at any point during the study
Measured: within 24 hours
Participants with hypotension requiring intervention
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PharmacologyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neha Parikh, Study director, INSYS Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641340
- Sponsor's protocol ID
- INS002-15-050
- Status last verified
- Mar 2016
- First submitted
- 23 Dec 2015
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rauck RL, Oh DA, Singla N, Koch C, Parikh N, Nalamachu S, Yu J, James S. Pharmacokinetics of Fentanyl Sublingual Spray in Opioid-Naive Participants: Results of a Phase 1, Multiple Ascending Dose Study. Clin Drug Investig. 2018 Aug;38(8):715-726. doi: 10.1007/s40261-018-0658-9.
PubMed 29909433Rauck RL, Oh DA, Singla N, Koch C, Parikh N, Nalamachu S, Wilson D, Yu J, Vetticaden S. Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a multiple ascending dose study in opioid-naive healthy volunteers. Curr Med Res Opin. 2017 Nov;33(11):1921-1933. doi: 10.1080/03007995.2017.1371681. Epub 2017 Sep 23.
PubMed 28942715
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fentanyl Sublingual Spray in Opioid Naive Subjects
- ClinicalTrials.gov ID
- NCT02641340
- Acronym / sponsor ID
- INS002-15-050
- Conditions
- Pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Dec 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 trial is to determine the pharmacokinetic and pharmacodynamic relationship of multiple dose administration of fentanyl sublingual spray in opioid naive participants. The secondary objective is to determine the safety and tolerability of multiple dose administration of fentanyl sublingual spray in opioid naive subjects.
Detailed description
For all cycles, blood will be drawn according to the following schedule:
The 0 time (pre-dose) blood sample will be collected within 60 minutes prior to first study drug administration.
Cohort l: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2, 4 (prior to second-dose), 4.083, 4.25, 4.5, 5, 6, 8 (prior to third-dose), 8.083, 8.25, 8.5, 9, 10, 12, 16 and 24 hours after the first dose.
Cohort 2: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2 (prior to second-dose), 2.083, 2.25, 2.5, 3, 4 (prior to third-dose), 4.083, 4.25, 4.5, 5, 6, 8, 10, 12, 16 and 24 hours after the first dose.
Cohort 3: 0 (pre-dose), 5, 15, 30 and 45 minutes after the first dose and at 1 (prior to second-dose), 1.083, 1.25, l.5, 1.75, 2 (prior to third-dose), 2.083, 2.25, 2.5, 2.75, 3, 4, 8, 12, 16 and 24 hours after the first dose.
Cohort 4: 0 (pre-dose), 5, 15, 30 (prior to the second-dose), 35, and 45 minutes after the first dose and at I (prior to the third-dose), 1.083, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 4, 8, 12, 16 and 24 hours after the first dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Cycle 1, Cohort 1 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFentanyl Sublingual Spray (FSS) low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every four hours for a maximum of three doses. |
| Cycle 1, Cohort 2 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every two hours for a maximum of three doses. |
| Cycle 1, Cohort 3 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every hour for a maximum of three doses. |
| Cycle 1, Cohort 4 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every 30 minutes for a maximum of three doses. |
| Cycle 2, Cohort 1 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every four hours for a maximum of three doses. |
| Cycle 2, Cohort 2 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every two hours for a maximum of three doses. |
| Cycle 2, Cohort 3 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every hour for a maximum of three doses. |
| Cycle 2, Cohort 4 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every 30 minutes for a maximum of three doses. |
| Cycle 3, Cohort 1 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every four hours for a maximum of three doses. |
| Cycle 3, Cohort 2 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every two hours for a maximum of three doses. |
| Cycle 3, Cohort 3 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every hour for a maximum of three doses. |
| Cycle 3, Cohort 4 | Experimental | Drug: Fentanyl Sublingual Spray, Drug: Fentanyl Citrate IVFSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every 30 minutes for a maximum of three doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meets protocol-specified criteria for qualification and contraception
- 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)
- 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:
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 SprayAlso: SUBSYS®Fentanyl delivered at low, medium and high doses by sublingual spray (FSS) | Drug | Cycle 1, Cohort 1, Cycle 1, Cohort 2, Cycle 1, Cohort 3, Cycle 1, Cohort 4, Cycle 2, Cohort 1, Cycle 2, Cohort 2, Cycle 2, Cohort 3, Cycle 2, Cohort 4, Cycle 3, Cohort 1, Cycle 3, Cohort 2, Cycle 3, Cohort 3, Cycle 3, Cohort 4 |
| Fentanyl Citrate IVFentanyl Citrate 50 mcg, delivered intravenously | Drug | Cycle 1, Cohort 1, Cycle 1, Cohort 2, Cycle 1, Cohort 3, Cycle 1, Cohort 4, Cycle 2, Cohort 1, Cycle 2, Cohort 2, Cycle 2, Cohort 3, Cycle 2, Cohort 4, Cycle 3, Cohort 1, Cycle 3, Cohort 2, Cycle 3, Cohort 3, Cycle 3, Cohort 4 |
Primary outcome
Maximum concentration (Cmax)
Time frame: within 24 hours (see detailed description)
Time to reach peak or maximum concentration following drug administration (Tmax)
Time frame: within 24 hours (see detailed description)
Area under the concentration-time curve
Time frame: within 24 hours (see detailed description)
Categories: during a dosing interval (AUCtau ), from the time of dosing to infinity (AUC0-inf), from the time of dosing to the last quantifiable time point (AUC0-t)
Apparent elimination rate constant in the terminal phase by non-compartmental analysis
Time frame: within 24 hours (see detailed description)
Corresponding half-life (t1/2)
Time frame: within 24 hours (see detailed description)
Trough concentration during multiple dosing prior to next dose (Ctrough)
Time frame: within 24 hours (see detailed description)
Accumulation ratios
Time frame: within 24 hours (see detailed description)
Categories: of Cmax (ARcmax), based on trough concentration (ARctrough), of AUCtau (ARauctau)
Dose normalized Cmax
Time frame: within 24 hours (see detailed description)
Dose normalized AUC
Time frame: within 24 hours (see detailed description)
Categories: AUC0-1, AUC0-inf, AUCtau
4 secondary outcomes
Participants with respiratory depression requiring the use of naloxone
Time frame: within 24 hours
Participants with hypoxia requiring oxygen administration
Time frame: within 24 hours
Participants needing noninvasive respiratory maneuvers (e.g., jaw thrust, bag-valve mask) to improve respiratory status at any point during the study
Time frame: within 24 hours
Participants with hypotension requiring intervention
Time frame: within 24 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 30 Mar 2016.
- Derived from this study: PubMed 29909433Rauck RL, Oh DA, Singla N, Koch C, Parikh N, Nalamachu S, Yu J, James S. Pharmacokinetics of Fentanyl Sublingual Spray in Opioid-Naive Participants: Results of a Phase 1, Multiple Ascending Dose Study. Clin Drug Investig. 2018 Aug;38(8):715-726. doi: 10.1007/s40261-018-0658-9.
- Derived from this study: PubMed 28942715Rauck RL, Oh DA, Singla N, Koch C, Parikh N, Nalamachu S, Wilson D, Yu J, Vetticaden S. Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a multiple ascending dose study in opioid-naive healthy volunteers. Curr Med Res Opin. 2017 Nov;33(11):1921-1933. doi: 10.1080/03007995.2017.1371681. Epub 2017 Sep 23.
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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.
Neha Parikh 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 Fentanyl Sublingual Spray and Fentanyl Citrate IV in people with Pharmacology, 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 30 Mar 2016. 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 concentration (Cmax) (time frame: within 24 hours (see detailed description)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02641340, which also lists 2 linked publications.
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 30 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.