A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers
Condition: Health
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics
      (how the drug is absorbed in the body, how it is distributed within the body and it is
      removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy
      volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and
      without food.
    

Detailed description: 
      JNJ-40346527 is an experimental drug that is being tested to see if it may be useful in
      treating of rheumatoid arthritis and other inflammatory diseases. This study will compare the
      effects (both good and bad) of JNJ-40346527 to those of placebo (which looks like the drug
      being studied but has no active ingredients) in healthy volunteers. This study will be the
      first study in which JNJ-40346527 is given to humans. This study is being conducted in three
      parts. Parts 1 and 2 are randomized (study drug will be assigned by chance), double-blind
      (neither the physician nor volunteer knows the identity of the assigned drug) studies
      comparing the safety and tolerability of JNJ-40346527 to placebo in 96 healthy volunteers.
      Part 3 is an open-label (all people involved know the identity of the assigned drug),
      2-period crossover (meaning that volunteers will receive both treatments at different times)
      study of the effects of food on JNJ-40346527 in 8 healthy male volunteers. For Part 1, the
      participation period is a maximum of 64 days, including a screening visit, a 5-day in-clinic
      period and three follow-up visits. For Part 2, the participation period is a maximum of 83
      days, including a screening visit, an 18-day in-clinic period and two follow-up visits. For
      Part 3, the participation period is a maximum of 59 days, including a screening visit, two
      4-day in-clinic periods separated by a 7 day break, and a follow-up visit. For all three
      parts of the study, safety evaluations, which will include ECG (a cardiac function test),
      vital signs and monitoring of side-effects will be performed. Additionally, blood and urine
      samples will be collected for evaluation. Volunteers will participate in 1 of 3 parts; Part
      1: volunteers will receive a single oral (by mouth) dose of JNJ-40346527 (10, 50, 150, 300,
      600, or 1000mg) or placebo; Part 2: volunteers will receive oral doses of JNJ-40346527 (50,
      150, 300, 500 or 750mg) or placebo once a day for 14 days; Part 3: volunteers will receive
      two oral doses of 150mg of JNJ-40346527 with and without food, with a 7-day break between
      doses.
    

Intervention name(s): JNJ-40346527/Placebo; JNJ-40346527/Placebo; JNJ-40346527
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of JNJ-40346527 (either 10, 50, 150, 300, 600, or 1000mg) or Placebo; JNJ-40346527 once daily oral dose for 14 days (either 50, 150, 300, 500 or 750mg) or Placebo; JNJ-40346527 150mg one dose, either fasting (or with food), then after 7 days off treatment, JNJ-40346527 150mg either with food (or fasting)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CR016795