Single Ascending Dose Study of MYK-461 in Healthy Volunteers

• Sponsor: MyoKardia, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02356289
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 8.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo; Drug: MYK-461	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 in Healthy Volunteers
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MYK-461 single-dose, tablet formulation	Drug: MYK-461
Placebo Comparator: Placebo single-dose, tablet formulation	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Safety: Incidence of adverse events [28 Days]

Secondary Outcome Measures

1. Determination of pharmacokinetics parameters [28 Days]

   maximum concentration (Cmax)

2. Determination of pharmacokinetics parameters [28 Days]

   time of the maximum measured concentration (Tmax)

3. Determination of pharmacokinetics parameters [28 Days]

   area under the concentrationtime curve (AUC)

4. Determination of pharmacokinetics parameters [28 Days]

   half-life (t1/2)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quintles LTD	London		United Kingdom

Sponsors and Collaborators

• MyoKardia, Inc.

Investigators

• Study Director: Jonathan C Fox, MD, PhD, MyoKardia, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MyoKardia, Inc.
• ClinicalTrials.gov Identifier: NCT02356289
• Other Study ID Numbers: MYK-461-002
• First Posted: Feb 5, 2015
• Last Update Posted: Sep 23, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by MyoKardia, Inc.: Hypertrophic Cardiomyopathy

Study Results

No Results Posted as of Sep 23, 2015