A Study of CK-1827452 Infusion in Stable Heart Failure

Summary

This study will assess the safety, tolerability, and pharmacodynamics of CK-1827452 infusion in patients with stable heart failure.

Timeline

Start

2007-04

Primary completion

2009-02

Completion

2009-02

Outcome

Met primary endpoint

registry analysis (unspecified test); >500 ng/mL; p <0.0001; LSM placebo corrected diff from baseline 80 (95% CI 71 to 89); ANCOVA NCT00624442 ↗

registry analysis (unspecified test); >500 ng/mL; p <0.0001; LSM placebo corrected diff from baseline 5 (95% CI 3 to 6); ANCOVA NCT00624442 ↗

Publications

• Vu T, Ma P, Xiao JJ, Wang YM, Malik FI, Chow AT. Population pharmacokinetic-pharmacodynamic modeling of omecamtiv mecarbil, a cardiac myosin activator, in healthy volunteers and patients with stable heart failure. J Clin Pharmacol. 2015 Nov;55(11):1236-47. doi: 10.1002/jcph.538. Epub 2015 Jul 14.
• Cleland JG, Teerlink JR, Senior R, Nifontov EM, Mc Murray JJ, Lang CC, Tsyrlin VA, Greenberg BH, Mayet J, Francis DP, Shaburishvili T, Monaghan M, Saltzberg M, Neyses L, Wasserman SM, Lee JH, Saikali KG, Clarke CP, Goldman JH, Wolff AA, Malik FI. The effects of the cardiac myosin activator, omecamtiv mecarbil, on cardiac function in systolic heart failure: a double-blind, placebo-controlled, crossover, dose-ranging phase 2 trial. Lancet. 2011 Aug 20;378(9792):676-83. doi: 10.1016/S0140-6736(11)61126-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omecamtiv Mecarbil	Small molecule	0.025 mg/kg	Intravenous
Subject	Omecamtiv Mecarbil	Small molecule	0.05 mg/kg	Intravenous
Subject	Omecamtiv Mecarbil	Small molecule	0.0625 mg/kg	Intravenous
Subject	Omecamtiv Mecarbil	Small molecule	0.1 mg/kg	Intravenous
Subject	Omecamtiv Mecarbil	Small molecule	0.125 mg/kg	Intravenous
Subject	Omecamtiv Mecarbil	Small molecule	0.25 mg/kg	Intravenous
Subject	Omecamtiv Mecarbil	Small molecule	0.375 mg/kg	Intravenous
Subject	Omecamtiv Mecarbil	Small molecule	0.5 mg/kg	Intravenous

Indications