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

• Status: Completed
• Trial end date: 2017-11-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MyoKardia, Inc.

Criteria

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.