Single Ascending Dose Study of MYK-461 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MYK-461; Drug: Placebo

• Registration Number: NCT02356289
• Lead Sponsor: MyoKardia, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MYK-461	MYK-461	single-dose, tablet formulation
Placebo	Placebo	single-dose, tablet formulation

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	28 Days

Secondary Outcome Measures

Name	Time	Method
Determination of pharmacokinetics parameters	28 Days	half-life (t1/2)

Trial Locations

Locations (1)

Quintles LTD; 🇬🇧 London, United Kingdom