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

M

MyoKardia

Status and phase

Completed
Phase 1

Conditions

Hypertrophic Cardiomyopathy

Treatments

Drug: MYK-461

Study type

Interventional

Funder types

Industry

Identifiers

NCT02329184
MYK-461-001

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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)..

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

MYK-461
Experimental group
Treatment:
Drug: MYK-461

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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