A Single Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of MYK-491

MyoKardia

Status and phase

Completed

Phase 1

Conditions

Dilated Cardiomyopathy

Treatments

Drug: MYK-491 or placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03062956

MYK-491-001

Details and patient eligibility

About

Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be monitored for safety and tolerability over a 7 day period.

Full description

Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be monitored for safety and tolerability over a 7 day period. After the 28 day screening period, the eligible subject will be admitted to the clinical site and will receive a single dose of study drug or placebo. Subjects will be confined to the clinical site for five days (Day -1 to Day 4) and will return to the clinic on Day 7 for a safety follow-up.

Enrollment

64 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Weight between 60 and 90 kg inclusive
Resting heart rate of < 80 beats per minute
Documented LVEF greater than or equal to 55% during Screening
Normal electrocardiogram (ECG) at Screening
Normal acoustic windows on transthoracic echocardiograms at Screening
All safety laboratory parameters within normal limits at Screening
History or evidence of another clinically significant disorder, in the opinion of the investigator.

Exclusion criteria

Active infection
History of coronary artery disease
History of malignancy with the exception of in situ cervical cancer more than 5 years prior to Screening or surgically-excised non-melanomatous skin cancers more than 2 years prior to Screening
Positive serology tests at screening
Current use of tobacco or nicotine-containing products exceeding 10 per day.