A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart Failure

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Criteria

Inclusion Criteria:

• Patients must have been diagnosed with heart failure

• Women must be either postmenopausal or have been surgically sterilized at least 6 months ago

• Males must be willing to use an acceptable birth control method for 3 months after the last dose of study medication.

Exclusion Criteria:

• Patients must not have had an heart-assist device or heart transplant or be in imminent need of one

• Patients must not have had an ischemic attack within the last 6 months or a heart attack within the last month

• Patients must not have lung disease or congenital heart failure.