Clinical trial NCT05362045: A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Mavacamten
Healthy Participants
Bioequivalence
Hypertrophic Cardiomyopathy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten 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, 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to approximately 1 month
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
timeFrame: Up to approximately 1 month
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
timeFrame: Up to approximately 1 month
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to approximately 1 month
measure: Terminal half-life (T-HALF)
timeFrame: Up to approximately 1 month
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 1 month
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to approximately 1 month
measure: Number of participants with vital sign abnormalities exceeding predefined thresholds
timeFrame: Up to approximately 1 month
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to approximately 1 month
measure: Number of participants with physical exam abnormalities
timeFrame: Up to approximately 1 month
measure: Number of participants with clinical laboratory evaluation abnormalities
timeFrame: Up to approximately 1 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical pharmacology of Miami
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Springfield
country: United States
facility: QPS Springfield
state: Missouri
city: Austin
country: United States
facility: Ppd Phase I Clinic
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: