A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety, tolerability, pharmacodynamics (how
      the study medication affects the body) and pharmacokinetics (how the drug is absorbed in the
      body, how it is distributed within the body and removed from the body over time) of an
      intravenous administration of JNJ-39588146 or placebo over a 3-hour period in patients with
      heart failure. The highest tolerated dose received during the first 3 hours of the study will
      be administered to some patients for an additional 18 hours. There will be up to 3 doses
      given throughout the administration period over a total of up to 21 hours.
    

Detailed description: 
      This study will assess the safety, tolerability, pharmacodynamics and pharmacokinetics of
      JNJ-39588146 or placebo (which looks like the drug being studied but has no active
      ingredients) in patients with heart failure. This study is being conducted in two parts. Part
      1 is a randomized (study drug will be assigned by chance), double-blind (neither the
      physician nor patient knows the identity of the assigned drug) study of 3 intravenous doses
      of JNJ-39588146 or placebo administered in 1-hr intervals (for a total of 3 hours) in 60
      patients with heart failure. Part 2 is an extended infusion of JNJ-39588146 and placebo that
      will administer the highest tolerated dose from Part 1 for an additional 18 hours. The entire
      duration of the infusion could be as long as 21 hours. There is a 1 in 4 chance of getting
      placebo. The participation period is a maximum of 42 days, including a screening visit, a
      2-day in-clinic period and two follow-up visits. For both parts of the study, patients will
      have a cardiac catheter in place to monitor heart function. Safety evaluations, which will
      include ECG (electrocardiograph, measuring the electrical currents in the heart), vital signs
      and monitoring of side-effects will be performed. Additionally, blood and urine samples will
      be collected for evaluation. Part 1: Patients will receive an intravenous (IV) solution of
      three different doses of JNJ-39588146 or placebo administered over 1 hour periods for a total
      of 3 hours. Part 2: Patients participating in the sub study will continue receiving an IV
      solution for 18 more hours for a total of up to 21 hours of administration.
    

Intervention name(s): JNJ-39588146 5 ng/kg/min; JNJ-39588146 15 ng/kg/min; JNJ-39588146 30 ng/kg/min; Placebo; JNJ-39588146 5, 15, or 30 ng/kg/min
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1-hour infusion of JNJ-39588146 5 ng/kg/min on Day 1; 1-hour infusion of JNJ-39588146 15 ng/kg/min on Day 1; 1-hour infusion of JNJ-39588146 30 ng/kg/min on Day 1; 1-hour infusion of matching placebo on Day 1; 18-hour infusion of JNJ-39588146 or matching placebo on Day 1 immediately folllowing the 3-hour infusion at a dose equal to the maximum dose tolerated by that patient during the 3-hour infusion in Part 1 of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Cardiac Failure