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

Healthy Participants Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05658146
• Other study ID #: CV027-1052
• Status: Completed
• Phase: Phase 1
• Start date: January 6, 2023
• Est. completion date: July 5, 2023

Study information

• Verified date: October 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Mavacamten Capsule 1
Specified dose on specified days
• Mavacamten Capsule 2
Specified dose on specified days
• Mavacamten Capsule 3
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Anaheim	California
United States	Local Institution - 0002	Miami	Florida
United States	Local Institution - 0003	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentration (Cmax)		From Day 1 up to Day 35±2 of each period
Primary	Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]		From Day 1 up to Day 35±2 of each period
Primary	Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]		From Day 1 up to Day 35±2 of each period
Secondary	Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)]		From Day 1 to Day 4 of each period
Secondary	Time of Maximum Observed Serum Concentration (Tmax)		From Day 1 up to Day 35±2 of each period
Secondary	Terminal Half-life (T-HALF)		From Day 1 up to Day 35±2 of each period
Secondary	Number of Participants with Adverse Events (AEs)		Up to 35 days post discontinuation of dosing
Secondary	Number of Participants with Serious Adverse Events (SAEs)		Up to 35 days post discontinuation of dosing
Secondary	Number of Participants with Vital Sign Abnormalities		Up to 35 days post discontinuation of dosing
Secondary	Number of Participants with Electrocardiograms (ECG) Abnormalities		Up to 35 days post discontinuation of dosing
Secondary	Number of Participants with Physical Examination Abnormalities		Up to 35 days post discontinuation of dosing
Secondary	Number of Participants with Clinical Laboratory Evaluation Abnormalities		Up to 35 days post discontinuation of dosing

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting