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

• Status: Completed
• Trial end date: 2019-10-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MyoKardia, Inc.

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.