Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01761565
First received: January 3, 2013
Last updated: January 26, 2015
Last verified: January 2015
  Purpose

Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs


Condition Intervention 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System in Healthy Subjects

Further study details as provided by AcelRx Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Cmax [ Time Frame: 24 hours in Treatment A, 37 hours in Treatment B ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration


Enrollment: 40
Study Start Date: January 2013
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761565

Locations
United States, Kansas
PRA
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
Principal Investigator: Sandra K. Willsie, D.O. PRA
  More Information

No publications provided

Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01761565     History of Changes
Other Study ID Numbers: IAP101
Study First Received: January 3, 2013
Results First Received: December 15, 2014
Last Updated: January 26, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 29, 2015