A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
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
1 other identifier
interventional
158
1 country
4
Brief Summary
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2022
Shorter than P25 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 5, 2022
CompletedStudy Start
First participant enrolled
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2022
CompletedNovember 21, 2022
November 1, 2022
3 months
May 2, 2022
November 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax)
Up to approximately 1 month
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
Up to approximately 1 month
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Up to approximately 1 month
Secondary Outcomes (8)
Time of maximum observed plasma concentration (Tmax)
Up to approximately 1 month
Terminal half-life (T-HALF)
Up to approximately 1 month
Number of participants with adverse events (AEs)
Up to approximately 1 month
Number of participants with serious adverse events (SAEs)
Up to approximately 1 month
Number of participants with vital sign abnormalities exceeding predefined thresholds
Up to approximately 1 month
- +3 more secondary outcomes
Study Arms (2)
Mavacamten- Dose A
EXPERIMENTALMavacamten- Dose B
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Clinical pharmacology of Miami
Miami, Florida, 33014, United States
Advanced Pharma CR, LLC
Miami, Florida, 33147, United States
QPS Springfield
Springfield, Missouri, 65802, United States
Ppd Phase I Clinic
Austin, Texas, 78744, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 5, 2022
Study Start
May 16, 2022
Primary Completion
August 19, 2022
Study Completion
August 19, 2022
Last Updated
November 21, 2022
Record last verified: 2022-11