v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Heart Failure With Reduced Ejection Fraction; Dilated Cardiomyopathy

Treatments: Drug: MYK-491; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03447990

MYK-491-003

Details and patient eligibility

About

The purpose of this Phase 1b/2a study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MYK-491 in patients with stable heart failure.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Has stable chronic heart failure with reduced ejection fraction
• Has adequate acoustic windows for echocardiography

Key Exclusion Criteria:

• Any significant structural cardiac abnormalities on Screening TTE
• At Screening, symptomatic hypotension or hypertension or bradycardia.
• Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, vasodilators [e.g., nesiritide], diuretics) or routinely scheduled ultrafiltration.
• Presence of protocol specified laboratory abnormalities at Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups

Part 1/SAD and Part 2/MAD - drug

Other group

Description:

Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo

Treatment:

Drug: MYK-491

Part 1/SAD and Part 2/MAD - placebo

Other group

Description:

Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo

Treatment:

Drug: Placebo