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Trial record 29 of 56 for:    insys

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

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 14, 2014
Last Update Posted Date December 12, 2014
Study Start Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
Maximum concentration (Cmax) by mode of administration [ Time Frame: within 36 hours after dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02138396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Bioavailability
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Fentanyl Sublingual Spray (FSS)
    • Drug: Fentanyl Citrate Injection (FCI)
    • Drug: Naltrexone
  • 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.
    Interventions:
    • Drug: Fentanyl Sublingual Spray (FSS)
    • Drug: Fentanyl Citrate Injection (FCI)
    • Drug: Naltrexone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2014)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02138396
Other Study ID Numbers  ICMJE INS-13-019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party INSYS Therapeutics Inc
Study Sponsor  ICMJE INSYS Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: George J Atiee, MD Worldwide Clinical Trials Early Phase Services, LLC
PRS Account INSYS Therapeutics Inc
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP