A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants

Healthy Participants Clinical Trial

Official title:

An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320094
• Other study ID #: CV027-043
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2022
• Est. completion date: September 11, 2022

Study information

• Verified date: October 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 11, 2022
• Est. primary completion date: September 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Mavacamten
Specified dose on specified days
• Activated Charcoal with Sorbitol
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))		Up to 2 months
Primary	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
Primary	Maximum observed plasma concentration (Cmax)		Up to 1 month
Secondary	Number of participants with adverse events (AEs)		Up to 3 months
Secondary	Number of participants with serious adverse events (SAEs)		Up to 3 months
Secondary	Number of participants with vital sign abnormalities exceeding predefined thresholds		Up to 3 months
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 3 Months
Secondary	Number of participants with physical exam abnormalities		Up to 3 months
Secondary	Number of participants with clinical laboratory evaluation abnormalities		Up to 3 months
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to 1 month
Secondary	Apparent terminal plasma half-life (T-HALF)		Up to 2 months
Secondary	Concentration at 24 hours (C24)		Up to 1 month

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls