Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Plasma Concentrations
• Intervention / Treatment: Drug: Single dose of SUF NT 15 mcg; Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Zalviso™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	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	24 hours in Treatment A, 37 hours in Treatment B
Time to Steady State	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)	24 hours
CST½	the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration	24

Collaborators and Investigators

• Sponsor: AcelRx Pharmaceuticals, Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Estimate): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 16, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: IAP101