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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Early Phase 1

Conditions

Healthy

Treatments

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02221726

FENPAI1024 (Other Identifier)

CR105188

Details and patient eligibility

About

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).

Full description

This study will assess 3 different scoring systems to evaluate the adhesive quality of "placebo" patch (an inactive patch that contains no active drug), JNJ-35685-AAA-G-023-G transdermal (through the skin) system. In this study, this patch is NOT being compared to a patch with a drug, and is NOT being used to test if the patch with the drug has a real effect in a clinical trial. The study consists 3 parts: Screening (21 days before study commences on Day 1), an adhesion assessment period (4 days), and an end of Study (EOS) assessment (recorded at 24 hours +/- 4 hours following patch removal). Total study duration per participant will be 26 days (including Screening). JNJ-35685-AAA-G-023 small (5.5 cm^2) and large (44 cm^2) patches will be applied on to left or right side of the paraspinal region based on randomization schedule. Adhesion assessments will be performed at patch application (hour 0, Baseline), and during the time interval of 8 to 10 hours, 24, 48, and 72 hours following patch application. Adhesion quality will be assessed by visual grading, United States Food and Drug Administration (FDA) scale, digital image analysis and visual grading grid system. Participants' safety will be monitored throughout the study.

Enrollment

16 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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