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

• Sponsor: MyoKardia, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02480296
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple Oral Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MYK-461 in Healthy Volunteers
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MYK-461 Oral Tablet x 28 days	Drug: MYK-461
Placebo Comparator: Placebo Oral Tablet x 28 days	Drug: Placebo; Placebo comparator

Outcome Measures

Primary Outcome Measures

1. Safety as measured by the incidence of adverse events [63 days]

   Incidence of adverse events

Secondary Outcome Measures

1. Determination of pharmacokinetic parameters [63 days]

   maximum concentration (Cmax)

2. Determination of pharmacokinetic parameters [63 days]

   time of the maximum measured concentration (Tmax)

3. Determination of pharmacokinetic parameters [63 days]

   area under the concentration time curve (AUC)

4. Determination of pharmacokinetic parameters [63 days]

   half-life (t1/2)

5. Characterize pharmacodynamic parameters [63 days]

   echocardiogram assessment

6. Characterize pharmacodynamic parameters [63 days]

   peak oxygen consumption

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Network	Melbourne	Victoria	Australia

Sponsors and Collaborators

• MyoKardia, Inc.

Investigators

• Study Director: Michael Grimm, MD, MyoKardia, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MyoKardia, Inc.
• ClinicalTrials.gov Identifier: NCT02480296
• Other Study ID Numbers: MYK461-003
• First Posted: Jun 24, 2015
• Last Update Posted: Mar 22, 2017
• Last Verified: Mar 1, 2017

Study Results

No Results Posted as of Mar 22, 2017