Fentanyl Sublingual Spray in Opioid Naive Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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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

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Pharmacology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

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.

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray

Intervention Type DRUG

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Fentanyl Citrate IV

Intervention Type DRUG

Fentanyl Citrate 50 mcg, delivered intravenously

Interventions

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Fentanyl Sublingual Spray

Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)

Intervention Type DRUG

Fentanyl Citrate IV

Fentanyl Citrate 50 mcg, delivered intravenously

Intervention Type DRUG

Other Intervention Names

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SUBSYS®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes