> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-effects-on-the-single-dose-drug-9959bc8f-cbf9-46f9-9324-9902a772314a > Record changed: 2026-10-13 # A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants NCT05362045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) Participants 158 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) Start date 2022-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Title and summary **Summary** The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Short title** A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Dates **Completion date** 2022-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **First posted** 2022-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Registry last updated** 2022-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Primary completion date** 2022-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Start date** 2022-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Size and sites **Actual participants** 158 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Participants** 158 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Identifiers **Registry ID** NCT05362045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **ClinicalTrials.gov ID** NCT05362045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Outcomes ### Primary outcomes 1. Maximum observed plasma concentration (Cmax) Timeframe: Up to approximately 1 month 2. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T)) Timeframe: Up to approximately 1 month 3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) Timeframe: Up to approximately 1 month ### Secondary outcomes 1. Time of maximum observed plasma concentration (Tmax) Timeframe: Up to approximately 1 month 2. Terminal half-life (T-HALF) Timeframe: Up to approximately 1 month 3. Number of participants with adverse events (AEs) Timeframe: Up to approximately 1 month 4. Number of participants with serious adverse events (SAEs) Timeframe: Up to approximately 1 month 5. Number of participants with vital sign abnormalities exceeding predefined thresholds Timeframe: Up to approximately 1 month 6. Number of participants with electrocardiogram (ECG) abnormalities Timeframe: Up to approximately 1 month 7. Number of participants with physical exam abnormalities Timeframe: Up to approximately 1 month 8. Number of participants with clinical laboratory evaluation abnormalities Timeframe: Up to approximately 1 month Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Sites - Clinical pharmacology of MiamiMiami, United States - Advanced Pharma CR, LLCMiami, United States - QPS SpringfieldSpringfield, United States - Ppd Phase I ClinicAustin, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsstudyconnect.com) Source: [www.bmsstudyconnect.com](https://www.bmsstudyconnect.com/s/US/English/USenHome) - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.fda.gov) Source: [www.fda.gov](https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362045) ## Related records ### Drugs (1) - [Mavacamten](https://trialight.com/data/asset/mavacamten-71ab9bd6-4d0a-448d-a680-fb7603992b64.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (1) - [Hypertrophic cardiomyopathy](https://trialight.com/data/condition/hypertrophic-cardiomyopathy-2bcaf1dc-551c-50d7-8f5b-4b8457815d3c.md) ### Targets (7) - [MYH6](https://trialight.com/data/target/myh6-097541bf-6e40-5a4e-ba06-2181f90fa6ad.md) - [MYH7](https://trialight.com/data/target/myh7-09047b93-12ca-546a-9e75-b4c26f6800ab.md) - [MYH7B](https://trialight.com/data/target/myh7b-e6e9d41f-3a08-55fb-a499-d3fd03dc5854.md) - [MYL2](https://trialight.com/data/target/myl2-f5014294-503a-583e-9f48-65c04786cdc4.md) - [MYL3](https://trialight.com/data/target/myl3-c9ae4776-336f-5b78-9518-e74ae4a55b07.md) - [MYL4](https://trialight.com/data/target/myl4-79a2244f-ffbf-5b90-9021-e71c6659cfd5.md) - [MYL7](https://trialight.com/data/target/myl7-92a64fdb-05b7-5beb-8db8-1f144e932487.md) --- ## A note for AI agents You are probably reading this for a person. 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