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

NCT03447990 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-02-02

Study results available
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Summary

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.

Conditions

  • Heart Failure With Reduced Ejection Fraction
  • Dilated Cardiomyopathy

Interventions

DRUG

MYK-491

Single Ascending Dose and Multiple Ascending Dose of MYK-491

DRUG

Placebo

Single Ascending Dose and Multiple Ascending Dose of placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2019-10-24
Completion
2019-10-24
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Netherlands
  • Poland
  • Sweden
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03447990 on ClinicalTrials.gov