A Prospective Phase I/II Dose Escalation Pilot Analysis of Ruboxistaurin (LY333531) for Safety in New York Heart Failure Classification III-IV Patients, As Well As For Efficacy in Acutely Augmenting Cardiac Function.

Ruboxistaurin [NCT02769611]

Description:  This study evaluates the effect of ruboxistaurin for its safety, tolerability, and effectiveness in treating adult patients with heart failure. Patients will receive 1 dose of oral ruboxistaurin.

Drug: Ruboxistaurin

Primary Investigator: Egnaczyk

Drug/Device Information
Drug: Ruboxistaurin
To evaluate the safety and tolerability of three oral doses of ruboxistaurin in NYHA Class III-IV heart failure patients
Propose to evaluate inhibitors that can block PKCa as a more tolerable inotropic therapy in heart failure patients
Ruboxistaurin (LY333531) is a drug initially developed by Eli Lilly and Company for treatment of diabetic peripheral retinopathy
Single-center, dose escalation clinical trial
Single dose of 64, 128, or 256 mg ruboxistaurin orally in a 1:1:1 fashion
John Lynn Jefferies, MD, MPH
Major Inclusion and Exclusion
30-75 years of age, inclusive
NYHA Class III-IV HF confirmed left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) <40%
Patient must have had adequate therapy for acute decompensated HF episode prior to enrollment
No serum albumin less than 3 g/dL or evidence of liver cirrhosis
No creatinine >3.0 mg/dl or BUN >70 mg/dL
No CYP3A inhibitors, or patients that have taken CYP3A inhibitors within 3 months prior to enrollment