HealthyPhase 1NCT02608320
A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Healthy Participants
A Phase 1 study testing Duragesic (Fentanyl Transdermal System [TDS] Small Patches), New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches) and Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Duragesic (Fentanyl Transdermal System [TDS] Small Patches), New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches) and Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2015to 13 Apr 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
- A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test at screening and urine pregnancy test at Day -1 of the first treatment period
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after completion of the study
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2), inclusive, and a body weight of not less than 50 kg
Who cannot join
- Participant has a history of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal insufficiency (creatinine clearance below 60 milliliter per minute [mL/min]); thyroid disease; neurologic or psychiatric disease; infection; or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening as deemed appropriate by the investigator
- Use of medications or treatments that would significantly influence or exaggerate patch adhesion or that would alter inflammatory or immune response to the study product (example antihistamines, systemic or topical corticosteroids, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy)
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening. Participants must not use tobacco products, including all nicotine use, example, cigarettes, cigars, chewing tobacco, patch, gum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Partially-blinded, Two-arm, Single-application, 3-way Crossover Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Subjects
The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.
Read the detailed description
This is a randomized (study medication assigned to participants by chance), single-center, parallel-group single-application, modified 3-way crossover study. Each participant will receive the marketed reference formulation (DURAGESIC) or the JNJ-35685-AAA-G016 or JNJ-35685-AAA-G021 fentanyl transdermal system (TDS). The study consists of a screening phase within 21 and 2 days before the first TDS application of the first period; a partially-blinded treatment phase consisting of 3 single-application treatment periods; and end-of-study or withdrawal assessments done upon completion of the 72-hour adhesion assessment on Day 5 of Period 3 or upon withdrawal. A 7- to 16-day washout period will separate the treatment periods, commencing at transdermal patch removal. The duration of participation in the study for an individual participant will be 31 days to a maximum of 68 days (including screening and follow-up visits). Participants will be primarily evaluated for cumulative adhesion percentage. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Duragesic (Fentanyl Transdermal System [TDS] Small Patches), New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches), Duragesic (Fentanyl TDS Large Patches), New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)
- Keywords
- Healthy, JNJ-35685-AAA-G016, JNJ-35685-AAA-G021, DURAGESIC, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duragesic (Fentanyl Transdermal System [TDS] Small Patches)Drug
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)Drug
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Drug
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Duragesic (Fentanyl TDS Large Patches)Drug
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Drug
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Drug
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence (ACB) Position (RLR) | Experimental | Participants will receive treatment A (Duragesic 12.5 microgram per hour [mcg/h]) applied to right paraspinal side in period 1, then treatment C (aged JNJ- 35685-AAA-G016 12.5 mcg/h) applied to left paraspinal side in period 2 and then treatment B (New JNJ-35685- AAA-G016 12.5 mcg/h) applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (BAC) Position (RLR) | Experimental | Participants will receive treatment B applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (CBA) Position (RLR) | Experimental | Participants will receive treatment C applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (BCA) Position (RLR) | Experimental | Participants will receive treatment B applied to right paraspinal side in period 1, then treatment C applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (CAB) Position (RLR) | Experimental | Participants will receive treatment C applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment B applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (ABC) Position (RLR) | Experimental | Participants will receive treatment A applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (ACB) Position (LRL) | Experimental | Participants will receive treatment A applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (BAC) Position (LRL) | Experimental | Participants will receive treatment B applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (CBA) Position (LRL) | Experimental | Participants will receive treatment C applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (BCA) Position (LRL) | Experimental | Participants will receive treatment B applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (CAB) Position (LRL) | Experimental | Participants will receive treatment C applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (ABC) Position (LRL) | Experimental | Participants will receive treatment A applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) |
| Treatment Sequence (DFE) Position (RLR) | Experimental | Participants will receive treatment D (Duragesic 100 mcg/h) applied to right paraspinal side in period 1, then treatment F (aged JNJ-35685-AAA-G021 100 mcg/h) applied to left paraspinal side in period 2 and then treatment E (new JNJ-35685-AAA-G021 100 mcg/h) applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (EDF) Position (RLR) | Experimental | Participants will receive treatment E applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (FED) Position (RLR) | Experimental | Participants will receive treatment F applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (EFD) Position (RLR) | Experimental | Participants will receive treatment E applied to right paraspinal side in period 1, then treatment F applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (FDE) Position (RLR) | Experimental | Participants will receive treatment F applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment E applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (DEF) Position (RLR) | Experimental | Participants will receive treatment D applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (DFE) Position (LRL) | Experimental | Participants will receive treatment D applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (EDF) Position (LRL) | Experimental | Participants will receive treatment E applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (FED) Position (LRL) | Experimental | Participants will receive treatment F applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (EFD) Position (LRL) | Experimental | Participants will receive treatment E applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (FDE) Position (LRL) | Experimental | Participants will receive treatment F applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
| Treatment Sequence (DEF) Position (LRL) | Experimental | Participants will receive treatment D applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3. Receives: Drug: Duragesic (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Adhesion Percentage
The actual percentages of patch adhesion will be estimated according to the Food and Drug Administration (FDA) 0-4 scoring system. An estimated percentage of adhesion, to a whole integer, will be obtained (FDA 0-4 [%] scoring) where 0=greater than or equal to (>=) 90% adhered (essentially no lift off the skin); 1= >= 75% to < 90% adhered (some edges only lifting off the skin); 2 = ≥ 50% to < 75% adhered (less than half of the patch lifting off the skin); 3 = > 0% to < 50% adhered but not detached (more than half of the patch lifting off the skin without falling off); 4 = 0% adhered - patch detached (patch completely off the skin).
Measured: Time of patch application up to patch removal (up to 72 hours)
Secondary outcomes (1)
Time to First Unacceptable Score
Time to first unacceptable score that is < 75% adhered will be assessed.
Measured: 12, 24, 36, 48, 60, and 72 hour following patch application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start17 Nov 2015
- Primary completion13 Apr 2016
- Study completion13 Apr 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608320
- Sponsor's protocol ID
- CR108060
- Other IDs
- FENPAI1025
- Status last verified
- Jan 2025
- First submitted
- 17 Nov 2015
- Last updated
- 3 Feb 2025
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partially-blinded, Two-arm, Single-application, 3-way Crossover Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02608320
- Acronym / sponsor ID
- CR108060
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-35685-AAA-G016, JNJ-35685-AAA-G021, DURAGESIC, Fentanyl
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 13 Apr 2016 (actual)
- Study completion
- 13 Apr 2016 (actual)
- First posted
- 18 Nov 2015 (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.
The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.
Detailed description
This is a randomized (study medication assigned to participants by chance), single-center, parallel-group single-application, modified 3-way crossover study. Each participant will receive the marketed reference formulation (DURAGESIC) or the JNJ-35685-AAA-G016 or JNJ-35685-AAA-G021 fentanyl transdermal system (TDS). The study consists of a screening phase within 21 and 2 days before the first TDS application of the first period; a partially-blinded treatment phase consisting of 3 single-application treatment periods; and end-of-study or withdrawal assessments done upon completion of the 72-hour adhesion assessment on Day 5 of Period 3 or upon withdrawal. A 7- to 16-day washout period will separate the treatment periods, commencing at transdermal patch removal. The duration of participation in the study for an individual participant will be 31 days to a maximum of 68 days (including screening and follow-up visits). Participants will be primarily evaluated for cumulative adhesion percentage. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 24
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence (ACB) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment A (Duragesic 12.5 microgram per hour [mcg/h]) applied to right paraspinal side in period 1, then treatment C (aged JNJ- 35685-AAA-G016 12.5 mcg/h) applied to left paraspinal side in period 2 and then treatment B (New JNJ-35685- AAA-G016 12.5 mcg/h) applied to right paraspinal side in period 3. |
| Treatment Sequence (BAC) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment B applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3. |
| Treatment Sequence (CBA) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment C applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3. |
| Treatment Sequence (BCA) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment B applied to right paraspinal side in period 1, then treatment C applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3. |
| Treatment Sequence (CAB) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment C applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment B applied to right paraspinal side in period 3. |
| Treatment Sequence (ABC) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment A applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3. |
| Treatment Sequence (ACB) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment A applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3. |
| Treatment Sequence (BAC) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment B applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3. |
| Treatment Sequence (CBA) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment C applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3. |
| Treatment Sequence (BCA) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment B applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3. |
| Treatment Sequence (CAB) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment C applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3. |
| Treatment Sequence (ABC) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches), Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches), Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Participants will receive treatment A applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3. |
| Treatment Sequence (DFE) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment D (Duragesic 100 mcg/h) applied to right paraspinal side in period 1, then treatment F (aged JNJ-35685-AAA-G021 100 mcg/h) applied to left paraspinal side in period 2 and then treatment E (new JNJ-35685-AAA-G021 100 mcg/h) applied to right paraspinal side in period 3. |
| Treatment Sequence (EDF) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment E applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3. |
| Treatment Sequence (FED) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment F applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3. |
| Treatment Sequence (EFD) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment E applied to right paraspinal side in period 1, then treatment F applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3. |
| Treatment Sequence (FDE) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment F applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment E applied to right paraspinal side in period 3. |
| Treatment Sequence (DEF) Position (RLR) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment D applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3. |
| Treatment Sequence (DFE) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment D applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3. |
| Treatment Sequence (EDF) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment E applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3. |
| Treatment Sequence (FED) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment F applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3. |
| Treatment Sequence (EFD) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment E applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3. |
| Treatment Sequence (FDE) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment F applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3. |
| Treatment Sequence (DEF) Position (LRL) | Experimental | Drug: Duragesic (Fentanyl TDS Large Patches), Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches), Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Participants will receive treatment D applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
- A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test at screening and urine pregnancy test at Day -1 of the first treatment period
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after completion of the study
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2), inclusive, and a body weight of not less than 50 kg
Key exclusion criteria (5 listed)
- Participant has a history of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal insufficiency (creatinine clearance below 60 milliliter per minute [mL/min]); thyroid disease; neurologic or psychiatric disease; infection; or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening as deemed appropriate by the investigator
- Use of medications or treatments that would significantly influence or exaggerate patch adhesion or that would alter inflammatory or immune response to the study product (example antihistamines, systemic or topical corticosteroids, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy)
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening. Participants must not use tobacco products, including all nicotine use, example, cigarettes, cigars, chewing tobacco, patch, gum
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 |
|---|---|---|
| Duragesic (Fentanyl Transdermal System [TDS] Small Patches)Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours. | Drug | Treatment Sequence (ABC) Position (LRL), Treatment Sequence (ABC) Position (RLR), Treatment Sequence (ACB) Position (LRL), Treatment Sequence (ACB) Position (RLR), Treatment Sequence (BAC) Position (LRL), Treatment Sequence (BAC) Position (RLR), Treatment Sequence (BCA) Position (LRL), Treatment Sequence (BCA) Position (RLR), Treatment Sequence (CAB) Position (LRL), Treatment Sequence (CAB) Position (RLR), Treatment Sequence (CBA) Position (LRL), Treatment Sequence (CBA) Position (RLR) |
| New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours. | Drug | Treatment Sequence (ABC) Position (LRL), Treatment Sequence (ABC) Position (RLR), Treatment Sequence (ACB) Position (LRL), Treatment Sequence (ACB) Position (RLR), Treatment Sequence (BAC) Position (LRL), Treatment Sequence (BAC) Position (RLR), Treatment Sequence (BCA) Position (LRL), Treatment Sequence (BCA) Position (RLR), Treatment Sequence (CAB) Position (LRL), Treatment Sequence (CAB) Position (RLR), Treatment Sequence (CBA) Position (LRL), Treatment Sequence (CBA) Position (RLR) |
| Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours. | Drug | Treatment Sequence (ABC) Position (LRL), Treatment Sequence (ABC) Position (RLR), Treatment Sequence (ACB) Position (LRL), Treatment Sequence (ACB) Position (RLR), Treatment Sequence (BAC) Position (LRL), Treatment Sequence (BAC) Position (RLR), Treatment Sequence (BCA) Position (LRL), Treatment Sequence (BCA) Position (RLR), Treatment Sequence (CAB) Position (LRL), Treatment Sequence (CAB) Position (RLR), Treatment Sequence (CBA) Position (LRL), Treatment Sequence (CBA) Position (RLR) |
| Duragesic (Fentanyl TDS Large Patches)Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours. | Drug | Treatment Sequence (DEF) Position (LRL), Treatment Sequence (DEF) Position (RLR), Treatment Sequence (DFE) Position (LRL), Treatment Sequence (DFE) Position (RLR), Treatment Sequence (EDF) Position (LRL), Treatment Sequence (EDF) Position (RLR), Treatment Sequence (EFD) Position (LRL), Treatment Sequence (EFD) Position (RLR), Treatment Sequence (FDE) Position (LRL), Treatment Sequence (FDE) Position (RLR), Treatment Sequence (FED) Position (LRL), Treatment Sequence (FED) Position (RLR) |
| New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours. | Drug | Treatment Sequence (DEF) Position (LRL), Treatment Sequence (DEF) Position (RLR), Treatment Sequence (DFE) Position (LRL), Treatment Sequence (DFE) Position (RLR), Treatment Sequence (EDF) Position (LRL), Treatment Sequence (EDF) Position (RLR), Treatment Sequence (EFD) Position (LRL), Treatment Sequence (EFD) Position (RLR), Treatment Sequence (FDE) Position (LRL), Treatment Sequence (FDE) Position (RLR), Treatment Sequence (FED) Position (LRL), Treatment Sequence (FED) Position (RLR) |
| Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours. | Drug | Treatment Sequence (DEF) Position (LRL), Treatment Sequence (DEF) Position (RLR), Treatment Sequence (DFE) Position (LRL), Treatment Sequence (DFE) Position (RLR), Treatment Sequence (EDF) Position (LRL), Treatment Sequence (EDF) Position (RLR), Treatment Sequence (EFD) Position (LRL), Treatment Sequence (EFD) Position (RLR), Treatment Sequence (FDE) Position (LRL), Treatment Sequence (FDE) Position (RLR), Treatment Sequence (FED) Position (LRL), Treatment Sequence (FED) Position (RLR) |
Primary outcome
Cumulative Adhesion Percentage
Time frame: Time of patch application up to patch removal (up to 72 hours)
The actual percentages of patch adhesion will be estimated according to the Food and Drug Administration (FDA) 0-4 scoring system. An estimated percentage of adhesion, to a whole integer, will be obtained (FDA 0-4 [%] scoring) where 0=greater than or equal to (>=) 90% adhered (essentially no lift off the skin); 1= >= 75% to < 90% adhered (some edges only lifting off the skin); 2 = ≥ 50% to < 75% adhered (less than half of the patch lifting off the skin); 3 = > 0% to < 50% adhered but not detached (more than half of the patch lifting off the skin without falling off); 4 = 0% adhered - patch detached (patch completely off the skin).
1 secondary outcome
Time to First Unacceptable Score
Time frame: 12, 24, 36, 48, 60, and 72 hour following patch application
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 3 Feb 2025.
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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?
A Phase 1 study testing Duragesic (Fentanyl Transdermal System [TDS] Small Patches), New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches) and Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 3 Feb 2025. 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 United States. 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?
Cumulative Adhesion Percentage (time frame: Time of patch application up to patch removal (up to 72 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2025.