A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Drug: Activated Charcoal with Sorbitol
- Registration Number
- NCT05320094
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mavacamten and activated charcoal with sorbitol - Dose B Activated Charcoal with Sorbitol - Mavacamten and activated charcoal with sorbitol - Dose A Activated Charcoal with Sorbitol - Mavacamten Mavacamten - Mavacamten and activated charcoal with sorbitol - Dose A Mavacamten - Mavacamten and activated charcoal with sorbitol - Dose B Mavacamten -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to 1 month 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
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 3 months Number of participants with serious adverse events (SAEs) Up to 3 months Time of maximum observed plasma concentration (Tmax) Up to 1 month Number of participants with vital sign abnormalities exceeding predefined thresholds Up to 3 months Number of participants with physical exam abnormalities Up to 3 months Concentration at 24 hours (C24) Up to 1 month Number of participants with electrocardiogram (ECG) abnormalities Up to 3 Months Number of participants with clinical laboratory evaluation abnormalities Up to 3 months Apparent terminal plasma half-life (T-HALF) Up to 2 months
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Dallas, Texas, United States