NCT03062956

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

Randomized, Placebo-Controlled Study of Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-491 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: MyoKardia, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dilated Cardiomyopathy

Interventions

Type	Name	Description
DRUG	MYK-491 or placebo	Oral suspension

Timeline

• Start date: 2017-01-16
• Primary completion: 2017-11-28
• Completion: 2017-11-28
• First posted: 2017-02-24
• Last updated: 2018-03-23

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study