Fentanyl Sublingual Spray in Opioid Naive Participants

March 28, 2016 updated by: INSYS Therapeutics Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Lotus Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cycle 1, Cohort 1
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 1, Cohort 2
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 1, Cohort 3
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 1, Cohort 4
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 2, Cohort 1
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 2, Cohort 2
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 2, Cohort 3
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 2, Cohort 4
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 3, Cohort 1
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 3, Cohort 2
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 3, Cohort 3
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously
Experimental: Cycle 3, Cohort 4
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Names:
  • SUBSYS®
Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration (Cmax)
Time Frame: within 24 hours (see detailed description)
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)
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)
within 24 hours (see detailed description)
Apparent elimination rate constant in the terminal phase by non-compartmental analysis
Time Frame: within 24 hours (see detailed description)
within 24 hours (see detailed description)
Corresponding half-life (t1/2)
Time Frame: within 24 hours (see detailed description)
within 24 hours (see detailed description)
Trough concentration during multiple dosing prior to next dose (Ctrough)
Time Frame: within 24 hours (see detailed description)
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)
within 24 hours (see detailed description)
Dose normalized Cmax
Time Frame: within 24 hours (see detailed description)
within 24 hours (see detailed description)
Dose normalized AUC
Time Frame: within 24 hours (see detailed description)
Categories: AUC0-1, AUC0-inf, AUCtau
within 24 hours (see detailed description)

Secondary Outcome Measures

Outcome Measure
Time Frame
Participants with respiratory depression requiring the use of naloxone
Time Frame: within 24 hours
within 24 hours
Participants with hypoxia requiring oxygen administration
Time Frame: within 24 hours
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
within 24 hours
Participants with hypotension requiring intervention
Time Frame: within 24 hours
within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

INSYS Therapeutics Inc

Investigators

  • Study Director: Neha Parikh, INSYS Therapeutics Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS002-15-050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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