Conditions: Heart Failure Myocardial Ischemia Angina Pectoris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 94
Healthy volunteers: no

Brief 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.

Arms:
arm 1: CK-1827452 I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr or placebo, followed by 6 days three times a day oral dose and a final single oral dose arm 2: CK-1827452 I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr or placebo, followed by 6 days three times a day oral dose and a final single oral dose

Interventions: intervention 1: CK-1827452 24mg and 6 mg iv infusion intervention 2: CK-1827452 12.5mg capsule intervention 3: CK-1827452 48 mg and 11 mg iv infusion intervention 4: CK-1827452 25mg capsule intervention 5: Placebo iv infusion intervention 6: Placebo capsule
Intervention descriptions: intervention 1: I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr intervention 2: 12.5mg oral immediate release capsule intervention 3: I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr intervention 4: 25mg oral immediate release capsule intervention 5: Matching placebo iv infusion intervention 6: Matching placebo oral immediate release capsule

Protocol document: