Effect of Delivery Route on PK of Sufentanil NanoTab

September 16, 2015 updated by: AcelRx Pharmaceuticals, Inc.

Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects

Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • body mass index 18 - 30

Exclusion Criteria:

  • pregnant females
  • smokers
  • pulmonary disease
  • sleep apnea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1 - Treatment A, B, C, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 2 - Treatment A, B, D, C
15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 3 - Treatment A, C, B, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 4 - Treatment A, C, D, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 5 - Treatment A, D, B, C
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)
Experimental: Sequence 6 - Treatment A, D, C, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual
Drug: Treatment A: Sufentanil IV
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Drug: Treatment B: Sufentanil NanoTab Sublingual
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Drug: Treatment C: Sufentanil NanoTab Buccal
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Drug: Treatment D: Sufentanil NanoTab Oral
Single Sufentanil NanoTab 15 mcg swallowed (PO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC (0 - Inf)
Time Frame: 24 hours
total amount of sufentanil absorbed
24 hours
Cmax
Time Frame: 24 hours
maximum plasma concentration
24 hours
Tmax
Time Frame: 24 hours
time to maximum plasma concentration
24 hours
CST 1/2
Time Frame: 24 hours
time for maximum plasma concentration to decrease by 50%
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AcelRx Pharmaceuticals, Inc.

Investigators

  • Study Director: Pamela Palmer, M.D., AcelRx Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 11, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 13, 2012

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAP102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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