A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

October 10, 2023 updated by: Bristol-Myers Squibb

An Open-label, Randomized, Single-dose, Three-way Crossover Study to Establish Bioequivalence of 5 mg Mavacamten Capsule 1 and 5 × 1 mg Mavacamten Capsule 2 to 5 mg Mavacamten Capsule 2 in Healthy Participants

The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Local Institution - 0001
    • Florida
      • Miami, Florida, United States, 33126
        • Local Institution - 0002
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Local Institution - 0003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Body mass index between 18 and 32 kilograms/meter squared (kg/m^2) inclusive, at the screening visit.
  • Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1.
  • Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.

Exclusion Criteria:

  • Any significant acute or chronic medical illness.
  • Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.
  • CYP2C19 poor (*2/*2, *3/*3, or *2/*3) or intermediate (*1/*2, *1/*3, *2/*17) metabolizer, as determined by genotyping during screening.
  • Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Drug: Mavacamten Capsule 1
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 2
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 3
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Experimental: Sequence 2
Drug: Mavacamten Capsule 1
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 2
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 3
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Experimental: Sequence 3
Drug: Mavacamten Capsule 1
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 2
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 3
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Experimental: Sequence 4
Drug: Mavacamten Capsule 1
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 2
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 3
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Experimental: Sequence 5
Drug: Mavacamten Capsule 1
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 2
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 3
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Experimental: Sequence 6
Drug: Mavacamten Capsule 1
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 2
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461
Drug: Mavacamten Capsule 3
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Serum Concentration (Cmax)
Time Frame: From Day 1 up to Day 35±2 of each period
From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
Time Frame: From Day 1 up to Day 35±2 of each period
From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Time Frame: From Day 1 up to Day 35±2 of each period
From Day 1 up to Day 35±2 of each period

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)]
Time Frame: From Day 1 to Day 4 of each period
From Day 1 to Day 4 of each period
Time of Maximum Observed Serum Concentration (Tmax)
Time Frame: From Day 1 up to Day 35±2 of each period
From Day 1 up to Day 35±2 of each period
Terminal Half-life (T-HALF)
Time Frame: From Day 1 up to Day 35±2 of each period
From Day 1 up to Day 35±2 of each period
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 35 days post discontinuation of dosing
Up to 35 days post discontinuation of dosing
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to 35 days post discontinuation of dosing
Up to 35 days post discontinuation of dosing
Number of Participants with Vital Sign Abnormalities
Time Frame: Up to 35 days post discontinuation of dosing
Up to 35 days post discontinuation of dosing
Number of Participants with Electrocardiograms (ECG) Abnormalities
Time Frame: Up to 35 days post discontinuation of dosing
Up to 35 days post discontinuation of dosing
Number of Participants with Physical Examination Abnormalities
Time Frame: Up to 35 days post discontinuation of dosing
Up to 35 days post discontinuation of dosing
Number of Participants with Clinical Laboratory Evaluation Abnormalities
Time Frame: Up to 35 days post discontinuation of dosing
Up to 35 days post discontinuation of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2023

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-1052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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