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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Mavacamten

• Registration Number: NCT05362045
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Study Start: 2022-05-16
• Primary Completion: 2022-08-19
• Study Completion: 2022-08-19
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mavacamten- Dose B	Mavacamten	-
Mavacamten- Dose A	Mavacamten	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Number of participants with electrocardiogram (ECG) abnormalities	Up to approximately 1 month
Number of participants with physical exam abnormalities	Up to approximately 1 month
Number of participants with clinical laboratory evaluation abnormalities	Up to approximately 1 month

Trial Locations

Locations (4)

Clinical pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Advanced Pharma CR, LLC; 🇺🇸 Miami, Florida, United States

QPS Springfield; 🇺🇸 Springfield, Missouri, United States

Ppd Phase I Clinic; 🇺🇸 Austin, Texas, United States