A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants
1 other identifier
interventional
45
1 country
1
Brief Summary
The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol 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 P50-P75 for phase_1
Started Apr 2022
Shorter than P25 for phase_1
1 active site
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
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2022
CompletedNovember 8, 2022
October 1, 2022
5 months
April 1, 2022
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Up to 2 months
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
Up to 2 months
Maximum observed plasma concentration (Cmax)
Up to 1 month
Secondary Outcomes (9)
Number of participants with adverse events (AEs)
Up to 3 months
Number of participants with serious adverse events (SAEs)
Up to 3 months
Number of participants with vital sign abnormalities exceeding predefined thresholds
Up to 3 months
Number of participants with electrocardiogram (ECG) abnormalities
Up to 3 Months
Number of participants with physical exam abnormalities
Up to 3 months
- +4 more secondary outcomes
Study Arms (3)
Mavacamten
EXPERIMENTALMavacamten and activated charcoal with sorbitol - Dose A
EXPERIMENTALMavacamten and activated charcoal with sorbitol - Dose B
EXPERIMENTALInterventions
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Body mass index between 18 and 30 kg/m\^2, inclusive, at the Screening Visit
- Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments
You may not qualify if:
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease
- History of sorbitol or fructose intolerance or inability to tolerate activated charcoal
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Dallas, Texas, 75247-4989, United States
Related Publications (1)
Merali S, Chiang M, Sychterz C, Chao L, Simmons T, Xu Y, Zhao A, Attanasio M, Murthy B, Perera V. Effect of Activated Charcoal on Mavacamten Pharmacokinetics in Healthy Participants. Am J Cardiovasc Drugs. 2024 Jul;24(4):569-575. doi: 10.1007/s40256-024-00659-z. Epub 2024 Jun 26.
PMID: 38926266DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
April 1, 2022
First Posted
April 11, 2022
Study Start
April 15, 2022
Primary Completion
September 11, 2022
Study Completion
September 11, 2022
Last Updated
November 8, 2022
Record last verified: 2022-10