Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

• 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: AcelRx Pharmaceuticals, Inc.
• Information provided by (Responsible Party): AcelRx Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: January 3, 2013
• First Posted Date: January 7, 2013
• Results First Submitted Date: December 15, 2014
• Results First Posted Date: February 11, 2015
• Last Update Posted Date: October 1, 2015
• Study Start Date: January 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: January 3, 2013): plasma concentration [ Time Frame: 24 hours ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Plasma Concentrations

Intervention

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2015): 40
• Original Enrollment: Not Provided
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01761565
• Other Study ID Numbers: IAP101
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AcelRx Pharmaceuticals, Inc.
• Study Sponsor: AcelRx Pharmaceuticals, Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sandra K. Willsie, D.O.; PRA

• PRS Account: AcelRx Pharmaceuticals, Inc.
• Verification Date: September 2015