NCT00682565

PK and Tolerability of IV and Oral CK-1827452 in Patients With Ischemic Cardiomyopathy and Angina

Tolerability and CK-1827452 Plasma Concentrations During Intravenous and Immediate-Release Oral CK-1827452 in Patients With Ischemic Cardiomyopathy and Angina

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy patients with angina is deleteriously affected by treatment with CK-1827452.

Detailed description

The primary objective of this study is to assess the effect of intravenous (i.v.) CK-1827452 on symptom-limited exercise tolerance in patients with ischemic cardiomyopathy and angina. The secondary objectives are to assess the tolerability of CK-1827452 administered three times daily (tid) to steady state in an immediate-release (IR), blend-in-capsule oral formulation to outpatients with ischemic cardiomyopathy and angina and to assess CK-1827452 plasma concentrations at trough and 1 hour after dosing with CK-1827452 administered tid to steady state in an IR, blend-in-capsule oral formulation to outpatients with ischemic cardiomyopathy and angina.

Conditions

• Heart Failure
• Myocardial Ischemia
• Angina Pectoris

Interventions

Type	Name	Description
DRUG	CK-1827452 24mg and 6 mg iv infusion	I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr
DRUG	CK-1827452 12.5mg capsule	12.5mg oral immediate release capsule
DRUG	CK-1827452 48 mg and 11 mg iv infusion	I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr
DRUG	CK-1827452 25mg capsule	25mg oral immediate release capsule
DRUG	Placebo iv infusion	Matching placebo iv infusion
DRUG	Placebo capsule	Matching placebo oral immediate release capsule

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-11-01
• Completion: 2009-03-01
• First posted: 2008-05-22
• Last updated: 2018-08-21
• Results posted: 2010-02-25

Locations

14 sites across 2 countries: Georgia, Russia