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

Trevena

Status and phase: Completed; Phase 1

Conditions: Heart Failure; Kidney Disease

Treatments: Drug: Normal Saline; Drug: TRV120027

Study type: Interventional

Funder types: Industry

Identifiers

NCT01444872

CP120027.1002

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 2 patient groups, including a placebo group

TRV120027

Experimental group

Description:

TRV120027 administered as an IV infusion

Treatment:

Drug: TRV120027

Normal Saline

Placebo Comparator group

Description:

Normal Saline administered as an IV infusion

Treatment:

Drug: Normal Saline