Clinical trial NCT05719805: A Study to Evaluate the Effects of Mavacamten in Healthy Participants
Official title: An Open-label, Randomized, Single-dose, 2-way Crossover Study to Establish Bioequivalence of 1 × 15-mg Mavacamten Capsule to 3 × 5-mg Mavacamten Capsules in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Hypertrophic cardiomyopathy (HCM)
Left ventricular (LV) hypertrophy
Bioequivalence
Left Ventricular Outflow Tract Obstruction
Heart diseases
Cardiovascular diseases
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 84
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 the study is to evaluate the effect between two different single doses of mavamten in healthy participants.


Eligibility criteria: 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, 12-lead ECGs, and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1. Participants with values outside of the normal range may be included if the values are not considered, by the investigator, to be clinically significant unless such values are explicitly excluded.
* Cytochrome P450 (CYP2C19) normal (\*1/\*1), rapid (\*1/\*17), or ultra-rapid (\*17/\*17) metabolizer, as determined by genotyping during screening.

Exclusion Criteria:

* Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, LV systolic dysfunction, coronary heart disease; current, history, or family history of HCM; or evidence of prior myocardial infarction based on ECGs.
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.
* Any gastrointestinal surgery (other than appendectomy) that, in the opinion of the investigator, could impact the absorption of study intervention.

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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Predose and post-dose up to Day 80
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
timeFrame: Predose and post-dose up to Day 80
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
timeFrame: Predose and post-dose up to Day 80
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Predose and post-dose up to Day 80
measure: Terminal Half-life (T-Half)
timeFrame: Predose and post-dose up to Day 80
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 80
measure: Number of Participants with Serious AEs (SAEs)
timeFrame: Up to Day 80
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to Day 80
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 80
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Up to Day 80
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to Day 80
Other outcomes:
Locations:
city: Miami
country: United States
facility: Local Institution - 0001
state: Florida
city: Saint Paul
country: United States
facility: Local Institution - 0002
state: Minnesota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: