HealthyPhase 1NCT01717157

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

A Phase 1 study testing Treatment A: DUROGESIC (8.4 mg fentanyl), Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl) and Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Treatment A: DUROGESIC (8.4 mg fentanyl), Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl) and Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteBelgium
Study dates: Aug 2012to Nov 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Study site
Antwerp

Other trials in Belgium

About this study

Official title: 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

Read the 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.

Conditions: Healthy
Being tested: Treatment A: DUROGESIC (8.4 mg fentanyl), Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl), Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl), Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl), Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Keywords: Healthy, Fentanyl, Transdermal patch, DUROGESIC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment A: DUROGESIC (8.4 mg fentanyl)Drug
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)Drug
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)Drug
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)Drug
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)Drug
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.

Study groups in NCT01717157
Study group	Role	What they receive
Treatment sequence 1 (AEBD)	Experimental	Not described Receives: Drug: Treatment A: DUROGESIC (8.4 mg fentanyl); Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl); Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl); Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 2 (BACE)	Experimental	Not described Receives: Drug: Treatment A: DUROGESIC (8.4 mg fentanyl); Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl); Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl); Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 3 (CBDA)	Experimental	Not described Receives: Drug: Treatment A: DUROGESIC (8.4 mg fentanyl); Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl); Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl); Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
Treatment sequence 4 (EDAC)	Experimental	Not described Receives: Drug: Treatment A: DUROGESIC (8.4 mg fentanyl); Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl); Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl); Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 5 (DECA)	Experimental	Not described Receives: Drug: Treatment A: DUROGESIC (8.4 mg fentanyl); Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl); Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl); Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 6 (EADB)	Experimental	Not described Receives: Drug: Treatment A: DUROGESIC (8.4 mg fentanyl); Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl); Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl); Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 7 (ABEC)	Experimental	Not described Receives: Drug: Treatment A: DUROGESIC (8.4 mg fentanyl); Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl); Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl); Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 8 (BCAD)	Experimental	Not described Receives: Drug: Treatment A: DUROGESIC (8.4 mg fentanyl); Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl); Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl); Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)

What is being measured

The primary outcome is the main question the study is designed to answer.

Fentanyl serum concentrations
Measured: Up to 120 hours after applying the transdermal patch
Determination of residual fentanyl content in the worn patchs
The fentanyl content in the patchs following their removal at the end of 72 hours
Measured: At the end of 72 hours after applying the transdermal patch
The skin adherence score of the patches
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.
Measured: Up to 72 hours after applying the transdermal patch

Secondary outcomes (1)

The incidence of adverse events
Measured: Approximately 82 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Nov 2012

First posted30 Oct 2012 (estimated)
Study startAug 2012
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01717157
Sponsor's protocol ID: CR100879
Other IDs: FENPAI1022, 2012-000705-71
Status last verified: Mar 2014
First submitted: 26 Oct 2012
Last updated: 6 Mar 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01717157
Acronym / sponsor ID: CR100879
Conditions: Healthy
Keywords: Healthy, Fentanyl, Transdermal patch, DUROGESIC
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 30 Oct 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Treatment sequence 1 (AEBD)	Experimental	Drug: Treatment A: DUROGESIC (8.4 mg fentanyl), Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl), Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl), Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 2 (BACE)	Experimental	Drug: Treatment A: DUROGESIC (8.4 mg fentanyl), Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl), Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl), Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 3 (CBDA)	Experimental	Drug: Treatment A: DUROGESIC (8.4 mg fentanyl), Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl), Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl), Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
Treatment sequence 4 (EDAC)	Experimental	Drug: Treatment A: DUROGESIC (8.4 mg fentanyl), Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl), Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl), Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 5 (DECA)	Experimental	Drug: Treatment A: DUROGESIC (8.4 mg fentanyl), Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl), Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl), Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 6 (EADB)	Experimental	Drug: Treatment A: DUROGESIC (8.4 mg fentanyl), Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl), Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl), Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 7 (ABEC)	Experimental	Drug: Treatment A: DUROGESIC (8.4 mg fentanyl), Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl), Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl), Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Treatment sequence 8 (BCAD)	Experimental	Drug: Treatment A: DUROGESIC (8.4 mg fentanyl), Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl), Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl), Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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 sequence 1 (AEBD), Treatment sequence 2 (BACE), Treatment sequence 3 (CBDA), Treatment sequence 4 (EDAC), Treatment sequence 5 (DECA), Treatment sequence 6 (EADB), Treatment sequence 7 (ABEC), Treatment sequence 8 (BCAD)
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 sequence 1 (AEBD), Treatment sequence 2 (BACE), Treatment sequence 3 (CBDA), Treatment sequence 6 (EADB), Treatment sequence 7 (ABEC), Treatment sequence 8 (BCAD)
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.	Drug	Treatment sequence 2 (BACE), Treatment sequence 3 (CBDA), Treatment sequence 4 (EDAC), Treatment sequence 5 (DECA), Treatment sequence 7 (ABEC), Treatment sequence 8 (BCAD)
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 sequence 1 (AEBD), Treatment sequence 3 (CBDA), Treatment sequence 4 (EDAC), Treatment sequence 5 (DECA), Treatment sequence 6 (EADB), Treatment sequence 8 (BCAD)
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 sequence 1 (AEBD), Treatment sequence 2 (BACE), Treatment sequence 4 (EDAC), Treatment sequence 5 (DECA), Treatment sequence 6 (EADB), Treatment sequence 7 (ABEC)

Primary outcome

Fentanyl serum concentrations
Time frame: 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
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.

1 secondary outcome

The incidence of adverse events
Time frame: Approximately 82 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fentanyl serum concentrations (time frame: Up to 120 hours after applying the transdermal patch). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01717157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2014; AzTrials last refreshed its copy on 6 Nov 2026.