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OpenTrials
Completed

NCT Number: NCT05658146

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mavacamten Capsule 1

Drug

Specified dose on specified days

Other names: BMS-986427, MYK-461

Mavacamten Capsule 2

Drug

Specified dose on specified days

Other names: BMS-986427, MYK-461

Mavacamten Capsule 3

Drug

Specified dose on specified days

Other names: BMS-986427, MYK-461

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: From Day 1 up to Day 35±2 of each period

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. Time of Maximum Observed Serum Concentration (Tmax)

    Time frame: From Day 1 up to Day 35±2 of each period

  3. Terminal Half-life (T-HALF)

    Time frame: From Day 1 up to Day 35±2 of each period

  4. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 35 days post discontinuation of dosing

  5. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to 35 days post discontinuation of dosing

  6. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to 35 days post discontinuation of dosing

  7. Number of Participants with Electrocardiograms (ECG) Abnormalities

    Time frame: Up to 35 days post discontinuation of dosing

  8. Number of Participants with Physical Examination Abnormalities

    Time frame: Up to 35 days post discontinuation of dosing

  9. Number of Participants with Clinical Laboratory Evaluation Abnormalities

    Time frame: Up to 35 days post discontinuation of dosing

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2022
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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