Clinical trial NCT05658146: A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy Participants
Mavacamten
Bioequivalence
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: From Day 1 up to Day 35±2 of each period
measure: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
timeFrame: From Day 1 up to Day 35±2 of each period
measure: Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
timeFrame: From Day 1 up to Day 35±2 of each period
Secondary outcomes:
measure: Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)]
timeFrame: From Day 1 to Day 4 of each period
measure: Time of Maximum Observed Serum Concentration (Tmax)
timeFrame: From Day 1 up to Day 35±2 of each period
measure: Terminal Half-life (T-HALF)
timeFrame: From Day 1 up to Day 35±2 of each period
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 35 days post discontinuation of dosing
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 35 days post discontinuation of dosing
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to 35 days post discontinuation of dosing
measure: Number of Participants with Electrocardiograms (ECG) Abnormalities
timeFrame: Up to 35 days post discontinuation of dosing
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Up to 35 days post discontinuation of dosing
measure: Number of Participants with Clinical Laboratory Evaluation Abnormalities
timeFrame: Up to 35 days post discontinuation of dosing
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution - 0001
state: California
city: Miami
country: United States
facility: Local Institution - 0002
state: Florida
city: Springfield
country: United States
facility: Local Institution - 0003
state: Missouri
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: