Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

September 30, 2016 updated by: AcelRx Pharmaceuticals, Inc.

IAP104 - Assessment of Pharmacokinetic Changes Following Concurrent Administration of Sufentanil NanoTab and Ketoconazole in Healthy Subjects

Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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:

  • 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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SUF NT 15 mcg
Period 1: One dose of SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
Drug: Sufentanil NanoTab (SUF NT) 15 mcg
Period 1: One dose of SUF NT 15 mcg administered sublingually
Other Names:
  • SUF NT 15 mcg
Experimental: Ketoconazole 400 mg, SUF NT 15 mcg

Ketoconazole 400 mg administered once daily for three days. One dose of SUF NT 15 mcg was co-administered sublingually with the third (last) ketoconazole dose.

Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
Drug: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day
Other Names:
  • SUF NT 15 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC (0-inf)
Time Frame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours
Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.
0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours
Cmax
Time Frame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.
Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.
0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.

Collaborators and Investigators

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

Sponsor

AcelRx Pharmaceuticals, Inc.

Investigators

  • Study Director: Pamela P. Palmer, MD, PhD, AcelRx Pharmaceuticals, Inc.

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

November 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 1, 2012

First Submitted That Met QC Criteria

November 1, 2012

First Posted (Estimate)

November 4, 2012

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAP104

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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