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Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

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ClinicalTrials.gov Identifier: NCT01761565
Recruitment Status : Completed
First Posted : January 7, 2013
Results First Posted : February 11, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 3, 2013
First Posted Date  ICMJE January 7, 2013
Results First Submitted Date  ICMJE December 15, 2014
Results First Posted Date  ICMJE February 11, 2015
Last Update Posted Date October 1, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2015)
  • Cmax [ Time Frame: 24 hours in Treatment A, 37 hours in Treatment B ]
    For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1. For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3
  • Time to Steady State [ Time Frame: 24 hours ]
    Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p >0.05)
  • CST½ [ Time Frame: 24 ]
    the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
plasma concentration [ Time Frame: 24 hours ]
Change History
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 Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Official Title  ICMJE Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects
Brief Summary Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Plasma Concentrations
Intervention  ICMJE
  • Drug: Single dose of SUF NT 15 mcg
  • Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
    Other Name: Zalviso™
Study Arms  ICMJE Experimental: Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg

Period 1: Single dose of SUF NT 15 mcg

Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

Interventions:
  • Drug: Single dose of SUF NT 15 mcg
  • Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Publications * Willsie SK, Evashenk MA, Hamel LG, Hwang SS, Chiang YK, Palmer PP. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015 Jan 1;37(1):145-55. doi: 10.1016/j.clinthera.2014.11.001. Epub 2014 Dec 24.

*   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: January 26, 2015)
40
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non smoking
  • Ages 18 to 45 year, inclusive
  • BMI between 18 and 30

Exclusion Criteria:

  • Subjects taking any prescription or OTC medications or vitamins or supplements
  • Pregnant females
  • Subjects with pulmonary disease or sleep apnea
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 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 NCT01761565
Other Study ID Numbers  ICMJE IAP101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AcelRx Pharmaceuticals, Inc.
Study Sponsor  ICMJE AcelRx Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandra K. Willsie, D.O. PRA
PRS Account AcelRx Pharmaceuticals, Inc.
Verification Date September 2015

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