The purpose of this study is to evaluate the safety of multiple oral doses of JNJ-39439335 and to assess how JNJ-39439335 is absorbed (taken in), distributed, metabolized (broken down), and eliminated from the body (referred to as pharmacokinetics) in osteoarthritis patients. This study will also assess the effectiveness of JNJ-39439335 on pain.
This will be a double-blind (patient and study staff will not know the identity of assigned treatment), randomized (assignment to 1 to 3 treatment groups will be by chance, like "flipping a coin"), placebo-controlled, multiple dose study conducted at up to two clinical sites. Up to 42 patients with osteoarthritis of the knee will be enrolled in 3 cohorts (Cohort 1 to 3). Additional cohorts (up to 14 patients per cohort) may be added after completion of Cohort 3. The study consists of eligibility screening, a treatment phase, and 4 follow-up visits. The study duration for each patient will be approximately 10 weeks. Patients safety will be closely monitored during the study by review of adverse events, electrocardiograms, vital signs (including oral temperature), clinical laboratory tests, and physical examinations. During specified study visits, blood samples will be collected for pharmacokinetics, pharmacodynamics (inpatient patients), and pharmacogenomic (optional) evaluations of JNJ-39439335. The effectiveness of JNJ-39439335 will be evaluated by assessing pain using an 11-point numerical rating scale and by the Western Ontario and McMaster Osteoarthritis Index. In Cohort 1 and 2, all patients will take their study medication orally, twice a day for 21 days. The treatment groups for Cohort 1 are JNJ-39439335 10 mg, naproxen 500 mg every 12 hours, and placebo. The treatment groups for Cohort 2 are JNJ-39439335 25 mg, naproxen 500 mg every 12 hours, and placebo. The treatment groups for Cohort 3 will be determined based on the results of Cohort 1 and 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
Placebo tablet/capsule every 12 hours for 21 days
2 x 25 mg tablets once daily for 21 days
500 mg capsule every 12 hours for 21 days
Unnamed facility
George, South Africa
Number of participants with adverse events as a measure of safety and tolerability
Time frame: From screening up to final follow up visit.
Change from baseline in vital signs, including oral body temperature
Time frame: From Day -1 up to final follow up visit
Change from baseline in ECG
Time frame: From Day -1 up to final follow up visit
Change from baseline in clinical laboratory tests
Time frame: From Day -1 up to final follow up visit
Concentaton of JNJ-39439335 in blood and urine samples
Time frame: From Day 1 up to final follow up visit
Concentration of JNJ-39439335 in blood and urine samples
Time frame: From Day 1 up to final follow up visit
Change from baseline in pain numerical rating scale
Time frame: From Day 2 up to final follow up visit
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time frame: From Day -1 up to final follow up visit
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2 x 5 mg tablets once daily for 21 days