Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461

Completed · Phase 1

Conditions studied: Hypertrophic Cardiomyopathy

In brief

The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.

Key facts

Study ID

NCT02329184

Run by

MyoKardia, Inc.

People needed

15

Starts

2014-12-01

Expected to finish

2016-04-01

Last updated by the study team

2016-09-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with HCM
• Normal left ventricular ejection fraction (LVEF)
• NYHA class I, II or III

You may not qualify if…

• Inherited metabolic disorders, myocardial infiltration or cardiofaciocutaneous syndrome (e.g., Noonan's, Fabry's).
• History of clinically important atrial or ventricular arrhythmias
• History of positive human immunodeficiency virus (HIV) test and/or seropositive for hepatitis C virus (HCV) or hepatitis B virus (HBV)..

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Cypress, California, United States
• Study site — Stanford, California, United States
• Study site — Boston, Massachusetts, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Durham, North Carolina, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.