A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362045
• Other study ID #: CV027-070
• Status: Completed
• Phase: Phase 1
• Start date: May 16, 2022
• Est. completion date: August 19, 2022

Study information

• Verified date: November 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 on the single-dose drug levels of mavacamten in healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 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 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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Mavacamten
Specified dose on specified days

Locations

Country	Name	City	State
United States	Ppd Phase I Clinic	Austin	Texas
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Clinical pharmacology of Miami	Miami	Florida
United States	QPS Springfield	Springfield	Missouri

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	Maximum observed plasma concentration (Cmax)		Up to approximately 1 month
Primary	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
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))		Up to approximately 1 month
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to approximately 1 month
Secondary	Terminal half-life (T-HALF)		Up to approximately 1 month
Secondary	Number of participants with adverse events (AEs)		Up to approximately 1 month
Secondary	Number of participants with serious adverse events (SAEs)		Up to approximately 1 month
Secondary	Number of participants with vital sign abnormalities exceeding predefined thresholds		Up to approximately 1 month
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to approximately 1 month
Secondary	Number of participants with physical exam abnormalities		Up to approximately 1 month
Secondary	Number of participants with clinical laboratory evaluation abnormalities		Up to approximately 1 month

External Links

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