Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults

NCT02221726 | Completed Early Phase 1

• 2 other identifiers: CR105188FENPAI1024
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive quality of placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial\]) JNJ-35685-AAA-G-023-G transdermal (through the skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch sizes (5.5 centimeter\^2 \[cm\^2\] and 44 cm\^2).

Conditions

Healthy

Keywords

Healthy; JNJ-35685-AAA-G-023; Placebo; Transdermal delivery device system

Outcome Measures

Primary Outcomes (3)

• Visual Grading United States Food and Drug Administration (FDA) Scale Score

  Visual grading US FDA scale will be used to evaluate adhesion performance of the transdermal system. The score ranges from 0-4: 0 = greater than or equal to (\>=) 90 percent (%) adhered (essentially no lift off the skin); 1 = greater than or equal to 75% to less than (\<) 90% adhered (some edges only lifting off the skin); 2 = greater than or equal to 50% to \<75% adhered (less than half of the patch lifting off the skin); 3 = greater than (\>) 0% to \<50% adhered but not detached (more than half of the patch lifting off the skin without falling off); and 4 = 0% adhered - patch detached (patch completely off the skin).

  Baseline up to 72 hours following patch application

• Adhesion Area Calculated by Digital Image Analysis

  Digital image will be captured with high resolution for each transdermal patch site and adhesion area will be calculated.

  Baseline up to 72 hours following patch application

• Total Adhesion Score Calculated by Visual Grading Grid System

  Total adhesion score will be calculated by visual grading grid system (a grid system based on 20 four-sided divisions that are approximately 5% of the total patch area; 44 cm\^2 patch will be evaluated by square and rectangular grid elements while 5.5 cm\^2 patch will be evaluated by square grid element only) which also contains a scale to allow for proper determination of actual area of the patch not adhering to the skin. Total area of the patch which does not adhere will be calculated. Any area of the patch that does not entirely adhere onto the skin will be scored as 0% adhesion for that area. Subsequently, a total adhesion score for that system will be calculated.

  Baseline up to 72 hours following patch application

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious AEs

  Baseline up to 72 hours following patch application

Study Arms (2)

JNJ-35684-AAA-023: 5.5 cm^2 Patch

EXPERIMENTAL

Drug: JNJ-35684-AAA-023: Size 1; small patch

JNJ-35684-AAA-023: 44 cm^2 Patch

EXPERIMENTAL

Drug: JNJ-35684-AAA-023: Size 2; large patch

Interventions

JNJ-35684-AAA-023: Size 1; small patch DRUG

Placebo (matched to Fentanyl transdermal delivery device system \[TDDS\]) JNJ-35685-AAA-G-023 TDDS, 5.5 centimeter square (cm\^2) will be applied vertically to 1 side of the paraspinal region, replicated 3 times, and worn for 72 hours.

JNJ-35684-AAA-023: 5.5 cm^2 Patch

JNJ-35684-AAA-023: Size 2; large patch DRUG

Placebo (matched to Fentanyl transdermal delivery device system \[TDDS\]) JNJ-35685-AAA-G-023 TDDS, 44 cm\^2 (Size 1; small patch) will be applied vertically to other side of the paraspinal region, replicated 3 times, and worn for 72 hours.

JNJ-35684-AAA-023: 44 cm^2 Patch

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI: weight in kilogram \[kg\]/height\^2 \[meter (m\^2)\]) between 18 and 35 kg/m\^2 (inclusive), and body weight not less than 50 kg
• Blood pressure (can be taken in supine or sitting position) between 90 and 140 milimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
• Non-smoker (for at least 6 months prior to screening) and willing to abstain from smoking during the study confinement period
• Good general health as determined by medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
• Willing to adhere to the prohibitions and restrictions specified in this protocol

You may not qualify if:

• 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 subject 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 15, 2014

Record last verified: 2014-09

Locations

US (1)