Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers

MyoKardia

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: MYK-461

Study type: Interventional

Funder types: Industry

Identifiers

NCT02480296

MYK461-003

Details and patient eligibility

About

The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose study in healthy volunteers aged 18-55 years.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal body mass index (BMI)
• Normal LVEF
• Normal electrocardiogram (ECG)
• Females must be non pregnant, non lactating and, if sexually active, be using an acceptable birth control method from the time of first dose through 3 months after the last dose of study drug

Exclusion criteria

• Any structural abnormalities on echocardiography
• Positive results of HIV test and/or seropositive for HCV or HBV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

MYK-461

Experimental group

Description:

Oral Tablet x 28 days

Treatment:

Drug: MYK-461

Placebo

Placebo Comparator group

Description:

Oral Tablet x 28 days

Treatment:

Drug: Placebo