Single Ascending Dose Study 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

NCT02356289

MYK-461-002

Details and patient eligibility

About

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

Enrollment: 48 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 not be breastfeeding and must be permanently sterilized or are postmenopausal.

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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48 participants in 2 patient groups, including a placebo group

MYK-461

Experimental group

Description:

single-dose, tablet formulation

Treatment:

Drug: MYK-461

Placebo

Placebo Comparator group

Description:

single-dose, tablet formulation

Treatment:

Drug: Placebo