NCT01761565

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 11, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1 month

First QC Date

January 3, 2013

Results QC Date

December 15, 2014

Last Update Submit

September 16, 2015

Conditions

Plasma Concentrations

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg

EXPERIMENTAL

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

Interventions

Single dose of SUF NT 15 mcgDRUG
Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg
40 consecutive doses of SUF NT 15 mcg taken every 20 minutesDRUG
Also known as: Zalviso™
Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Subjects taking any prescription or OTC medications or vitamins or supplements
  • Pregnant females
  • Subjects with pulmonary disease or sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

  • 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.

    PMID: 25544247BACKGROUND

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Pamela Palmer, MD, PhD
Organization
AcelRx Pharmaceuticals, Inc.
ppalmer@acelrx.com
650-216-3504

Study Officials

  • Sandra K. Willsie, D.O.

    PRA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 7, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

October 1, 2015

Results First Posted

February 11, 2015

Record last verified: 2015-09

Locations

US(1)