Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs

Condition or disease Intervention/treatment Phase
Plasma Concentrations Drug: Single dose of SUF NT 15 mcg Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects
Study Start Date : January 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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

 Drug: Single dose of SUF NT 15 mcg
Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Other Name: Zalviso™


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


  2. 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)

  3. CST½ [ Time Frame: 24 ]
    the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01761565


Locations
Layout table for location information
United States, Kansas
PRA
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Sandra K. Willsie, D.O. PRA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01761565    
Other Study ID Numbers: IAP101
First Posted: January 7, 2013    Key Record Dates
Results First Posted: February 11, 2015
Last Update Posted: October 1, 2015
Last Verified: September 2015