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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches); Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Drug: Duragesic (Fentanyl TDS Large Patches); Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02608320

CR108060

FENPAI1025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

52 participants in 24 patient groups

Treatment Sequence (ACB) Position (RLR)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (BAC) Position (RLR)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (CBA) Position (RLR)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (BCA) Position (RLR)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (CAB) Position (RLR)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (ABC) Position (RLR)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (ACB) Position (LRL)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (BAC) Position (LRL)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (CBA) Position (LRL)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (BCA) Position (LRL)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (CAB) Position (LRL)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (ABC) Position (LRL)

Experimental group

Description:

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:

Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

Treatment Sequence (DFE) Position (RLR)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (EDF) Position (RLR)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (FED) Position (RLR)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (EFD) Position (RLR)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (FDE) Position (RLR)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (DEF) Position (RLR)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (DFE) Position (LRL)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (EDF) Position (LRL)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (FED) Position (LRL)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (EFD) Position (LRL)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (FDE) Position (LRL)

Experimental group

Description:

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:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Treatment Sequence (DEF) Position (LRL)

Experimental group

Description:

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.

Treatment:

Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Drug: Duragesic (Fentanyl TDS Large Patches)

Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)