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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT02221726

Run by

Janssen Research & Development, LLC

People needed

16

Starts

2014-08-01

Expected to finish

2014-08-01

Last updated by the study team

2014-09-15

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

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

Where it is running

• Study site — Cypress, California, United States

Full record on ClinicalTrials.gov

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