A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers

March 5, 2014 updated by: Janssen Research & Development, LLC

An Open-Label, Randomized, 4-Way Crossover Study to Assess the Relative Bioavailability of 4 New Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Subjects

The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), 4-way crossover (participants will receive different interventions sequentially during the trial) study. The study will assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of 4 new formulations of fentanyl transdermal patch, TDS-Concept 1 50 µg/h, TDS-Concept 2 50 µg/h, TDS-Concept 3 50 µg/h and TDS-Concept 4 100 µg/h compared with DUROGESIC fentanyl 50 µg/h in healthy participants after a single application. All participants will be randomly assigned to 1 of 8 possible treatment sequences. During the 4 single-application treatment periods, each transdermal patch will be worn, on a different application site on the lateral side of the upper arm, continuously for 72 hours. The treatment periods will be separated by a washout period (period when receiving no treatment) of at least 8 and no more than 14 days. The total study length is from 64 days to a maximum of 82 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
  • Participants must utilize a medically acceptable method of contraception throughout the entire study period including the washout period and for 3 months (men) or 1 week (women) after the study is completed
  • Men must not donate sperm from the first drug administration until 3 months after completion of the study
  • Each participant will receive a test for opioid dependency. Only those participants that pass this challenge test will be allowed to continue in this study
  • Non-smoker

Exclusion Criteria:

  • History of or current clinically significant medical illness, disease or condition that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
  • Clinically significant abnormal laboratorial values
  • Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
  • History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment sequence 1 (AEBD)
Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 2 (BACE)
Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 3 (CBDA)
Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 4 (EDAC)
Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 5 (DECA)
Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 6 (EADB)
Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 7 (ABEC)
Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 8 (BCAD)
Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fentanyl serum concentrations
Time Frame: Up to 120 hours after applying the transdermal patch
Up to 120 hours after applying the transdermal patch
Determination of residual fentanyl content in the worn patchs
Time Frame: At the end of 72 hours after applying the transdermal patch
The fentanyl content in the patchs following their removal at the end of 72 hours
At the end of 72 hours after applying the transdermal patch
The skin adherence score of the patches
Time Frame: Up to 72 hours after applying the transdermal patch
The patch adherence will be scored from 0 to 4, where 0: >= 90% of the area adhered and no edges unattached; 1: >= 75% to < 90% adhered; 2: >= 50% and < 75% adhered; 3: > 0% and < 50% adhered, but not detached; 4: 0% adhered - patch detached.
Up to 72 hours after applying the transdermal patch

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The incidence of adverse events
Time Frame: Approximately 82 days
Approximately 82 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR100879
  • FENPAI1022 (Other Identifier: Janssen Research & Development, LLC)
  • 2012-000705-71 (EudraCT Number)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings