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Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT02138396
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Bioavailability Drug: Fentanyl Sublingual Spray (FSS) Drug: Fentanyl Citrate Injection (FCI) Drug: Naltrexone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : January 2014
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FSS first, then FCI
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.
Drug: Fentanyl Sublingual Spray (FSS)
A single dose of fentanyl, 400 mcg per sublingual spray
Other Name: Subsys®

Drug: Fentanyl Citrate Injection (FCI)
A single dose of fentanyl citrate, 100 mcg per intramuscular injection

Drug: Naltrexone
Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.

Experimental: FCI first, then FSS
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.
Drug: Fentanyl Sublingual Spray (FSS)
A single dose of fentanyl, 400 mcg per sublingual spray
Other Name: Subsys®

Drug: Fentanyl Citrate Injection (FCI)
A single dose of fentanyl citrate, 100 mcg per intramuscular injection

Drug: Naltrexone
Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.




Primary Outcome Measures :
  1. Maximum concentration (Cmax) by mode of administration [ Time Frame: within 36 hours after dosing ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138396


Locations
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United States, Texas
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Principal Investigator: George J Atiee, MD Worldwide Clinical Trials Early Phase Services, LLC

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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02138396     History of Changes
Other Study ID Numbers: INS-13-019
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Fentanyl
Naltrexone
Citric Acid
Sodium Citrate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Alcohol Deterrents
Narcotic Antagonists