Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trevena Inc.

Criteria

Inclusion Criteria:

• Written Informed Consent

• Heart Failure

• Mild to moderate renal dysfunction

• Age 18- <75

• Males and females (non-childbearing potential)

Exclusion Criteria:

• Any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the Investigator based on medical history, physical examination or laboratory tests

• Any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the Investigator

• Allergy or clinically-significant intolerance to ARBs or ACE inhibitors

• Clinical signs or symptoms of acute decompensated heart failure

• Pregnant or lactating