Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction

• Status: Completed
• Trial end date: 2017-05-08
• Target enrollment: 0
• Participant gender: All

Summary

• To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart failure (HF) with reduced ejection fraction

• To evaluate the safety and tolerability of oral omecamtiv mecarbil

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

Details

• Lead Sponsor: Amgen; Cytokinetics

Criteria

Inclusion Criteria:

• Japanese male or female ≥ 20 years and ≤ 85 years of age

• History of chronic stable heart failure (HF) with reduced ejection fraction, defined as requiring treatment for HF for a minimum of 4 weeks prior to screening

• Treated for HF with optimal pharmacological therapy

• Left ventricular ejection fraction ≤ 40% at screening

Exclusion Criteria:

• Severe uncorrected valvular heart disease

• Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease

• Acute myocardial infarction, unstable angina, or persistent angina at rest within 30 days prior to randomization

• Systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg, or heart rate (HR) > 110 beats per minute (bpm) or HR < 50 bpm

• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2

• Total bilirubin (TBL) ≥ 2x upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3x ULN Other Exclusion Criteria may apply.