NCT00624442

A Study of CK-1827452 Infusion in Stable Heart Failure

A Phase II, Multi Center, Double-Blind, Randomized, Placebo Controlled, Dose-Escalation, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CK-1827452 in Patients With Stable Heart Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	CK-1827452	IV infusion for 1 hour at 0.125 mg/kg/h followed by 1 hour at 0.0625 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 0.75 mg/kg/h followed by 1 hour at 0.375 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h followed by 22 hours at 0.025 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h followed by 22 hours at 0.05 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h followed by 22 hours at 0.1 mg/kg/h
DRUG	Placebo	IV infusion for 2 hours
DRUG	Placebo	IV infusion for 24 hours
DRUG	CK-1827452	IV infusion for 1 hour at 1.0 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
DRUG	Placebo	IV infusion for 72 hours
DRUG	CK-1827452	IV infusion for 1 hour at 0.75 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 0.25 mg/kg/h followed by 23 hours at 0.025 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 0.5 mg/kg/h followed by 23 hours at 0.05 mg/kg/h
DRUG	CK-1827452	IV infusion for 1 hour at 1.0 mg/kg/h followed by 23 hours at 0.1 mg/kg/h

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-02-27
• Last updated: 2021-05-14
• Results posted: 2010-08-16

Locations

17 sites across 4 countries: United States, Georgia, Russia, United Kingdom