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

November 17, 2022 updated by: Bristol-Myers Squibb

Bioequivalence Study of a Single Dose of 15-mg Mavacamten Capsule Versus a Single Dose of 3 x 5-mg Mavacamten Capsules in Healthy Participants

The purpose of this study is to evaluate 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)

158

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
    • Florida
      • Miami, Florida, United States, 33147
        • Advanced Pharma CR, LLC
      • Miami, Florida, United States, 33014
        • Clinical Pharmacology of Miami
    • Missouri
      • Springfield, Missouri, United States, 65802
        • QPS Springfield
    • Texas
      • Austin, Texas, United States, 78744
        • PPD Phase I Clinic

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index between 18 and 32 kg/m^2, inclusive, at the Screening Visit
  • Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments within the normal range at the screening visit and/or on Day -1

Exclusion Criteria:

  • Current or recent (within 3 months of study intervention administration) gastrointestinal disease
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)

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: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mavacamten- Dose A
Drug: Mavacamten
Specified dose on specified days
Other Names:
  • BMS-986427
  • MYK-461
EXPERIMENTAL: Mavacamten- Dose B
Drug: Mavacamten
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 plasma concentration (Cmax)
Time Frame: Up to approximately 1 month
Up to approximately 1 month
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
Time Frame: Up to approximately 1 month
Up to approximately 1 month
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Time Frame: Up to approximately 1 month
Up to approximately 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to approximately 1 month
Up to approximately 1 month
Terminal half-life (T-HALF)
Time Frame: Up to approximately 1 month
Up to approximately 1 month
Number of participants with adverse events (AEs)
Time Frame: Up to approximately 1 month
Up to approximately 1 month
Number of participants with serious adverse events (SAEs)
Time Frame: Up to approximately 1 month
Up to approximately 1 month
Number of participants with vital sign abnormalities exceeding predefined thresholds
Time Frame: Up to approximately 1 month
Up to approximately 1 month
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to approximately 1 month
Up to approximately 1 month
Number of participants with physical exam abnormalities
Time Frame: Up to approximately 1 month
Up to approximately 1 month
Number of participants with clinical laboratory evaluation abnormalities
Time Frame: Up to approximately 1 month
Up to approximately 1 month

Collaborators and Investigators

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

Sponsor

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)

May 16, 2022

Primary Completion (ACTUAL)

August 19, 2022

Study Completion (ACTUAL)

August 19, 2022

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (ACTUAL)

May 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CV027-070

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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