Single Ascending Dose Study of MYK-461 in Healthy Volunteers

MyoKardia, Inc.48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

PlaceboDRUG

MYK-461DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Quintles LTD

London, United Kingdom

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time frame: 28 Days

Secondary Outcomes

Determination of pharmacokinetics parameters

maximum concentration (Cmax)

Time frame: 28 Days

Determination of pharmacokinetics parameters

time of the maximum measured concentration (Tmax)

Time frame: 28 Days

Determination of pharmacokinetics parameters

area under the concentrationtime curve (AUC)

Time frame: 28 Days

Determination of pharmacokinetics parameters

half-life (t1/2)

Time frame: 28 Days

Data from ClinicalTrials.gov

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