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

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.

Timeline

Start

2010-06

Primary completion

2011-09

Completion

2011-09

Outcome

Mixed primary results

registry p = 0.0215; Mean Difference (Final Values) 0.33 (90% CI 0.064 to 0.595) NCT01120210 ↗

registry p = 0.4729; Mean Difference (Final Values) -0.09 (90% CI -2.312 to 2.131) NCT01120210 ↗

paper No statistically significant reductions in pulmonary capillary wedge pressure (PCWP) were seen with any dose tested in the primary analysis PMID 23471413 ↗

Publications

• Gheorghiade M, Greene SJ, Ponikowski P, Maggioni AP, Korewicki J, Macarie C, Metra M, Grzybowski J, Bubenek-Turconi SI, Radziszewski W, Olson A, Bueno OF, Ghosh A, Deckelbaum LI, Li LY, Patel AR, Koester A, Konstam MA. Haemodynamic effects, safety, and pharmacokinetics of human stresscopin in heart failure with reduced ejection fraction. Eur J Heart Fail. 2013 Jun;15(6):679-89. doi: 10.1093/eurjhf/hft023. Epub 2013 Mar 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-39588146	Unknown	5 unknown	Intravenous
Subject	JNJ-39588146	Unknown	15 unknown	Intravenous
Subject	JNJ-39588146	Unknown	30 unknown	Intravenous

Indications