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Trial record 15 of 56 for:    insys

Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects

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ClinicalTrials.gov Identifier: NCT02576353
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE October 13, 2015
First Posted Date  ICMJE October 15, 2015
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE October 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
  • Maximum concentration [ Time Frame: 0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing ]
  • Time to maximum concentration [ Time Frame: 0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing ]
  • Area under the plasma concentration-time curve from 0 to the final time with a concentration at or above the limit of quantitation (LoQ) [ Time Frame: 0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing ]
  • Area under the plasma concentration-time curve from 0 to infinity [ Time Frame: 0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing ]
  • Apparent elimination rate constant in the terminal phase by noncompartmental analysis [ Time Frame: 0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing ]
  • Elimination half-life [ Time Frame: 0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing ]
  • Apparent oral clearance of drug following extravascular administration [ Time Frame: 0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing ]
  • Volume of distribution during terminal phase following extravascular administration [ Time Frame: 0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02576353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects
Official Title  ICMJE A Phase 1, Open-label, Randomized, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects
Brief Summary The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The secondary objective is to determine the safety and tolerability of fentanyl sublingual spray in opioid naive subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacokinetics and Pharmacodynamics
Intervention  ICMJE
  • Drug: Fentanyl
    Fentanyl Sublingual Spray (FSS)
  • Drug: Fentanyl Citrate
    Fentanyl Citrate IV (FCIV)
Study Arms  ICMJE
  • Experimental: Cohort 1
    After a 10-hour fast, the 10 participants in this cohort are randomized to receive Fentanyl Sublingual (under the tongue) Spray (FSS) 100 mcg (n=8), or Fentanyl Citrate Intravenously (FCIV) 50 mcg (n=2).
    Interventions:
    • Drug: Fentanyl
    • Drug: Fentanyl Citrate
  • Experimental: Cohort 2
    After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 200 mcg (n=8), or FCIV 50 mcg (n=2).
    Interventions:
    • Drug: Fentanyl
    • Drug: Fentanyl Citrate
  • Experimental: Cohort 3
    After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 400 mcg (n=8), or FCIV 50 mcg (n=2).
    Interventions:
    • Drug: Fentanyl
    • Drug: Fentanyl Citrate
  • Experimental: Cohort 4
    After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 600 mcg (n=8), or FCIV 50 mcg (n=2).
    Interventions:
    • Drug: Fentanyl
    • Drug: Fentanyl Citrate
  • Experimental: Cohort 5
    After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 800 mcg (n=8), or FCIV 50 mcg (n=2).
    Interventions:
    • Drug: Fentanyl
    • Drug: Fentanyl Citrate
Publications * Rauck R, Oh DA, Parikh N, Koch C, Singla N, Yu J, Nalamachu S, Vetticaden S. Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a single ascending dose study in opioid-naïve healthy volunteers. Curr Med Res Opin. 2017 Nov;33(11):1915-1920. doi: 10.1080/03007995.2017.1352496. Epub 2017 Aug 11.

*   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: October 13, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT02576353
Other Study ID Numbers  ICMJE INS002-15-049
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
Study Director: Neha N Parikh INSYS Therapeutics Inc
PRS Account INSYS Therapeutics Inc
Verification Date November 2015

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