A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
- Summary
- The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
- Short title
- A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2022-08-19
- First posted
- 2022-05-05
- Registry last updated
- 2022-11-21
- Primary completion date
- 2022-08-19
- Start date
- 2022-05-16
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Bristol-Myers Squibb
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05362045
- ClinicalTrials.gov ID
- NCT05362045
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Maximum observed plasma concentration (Cmax)
Timeframe: 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))
Timeframe: Up to approximately 1 month
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Timeframe: Up to approximately 1 month
Time of maximum observed plasma concentration (Tmax)
Timeframe: Up to approximately 1 month
Terminal half-life (T-HALF)
Timeframe: Up to approximately 1 month
Number of participants with adverse events (AEs)
Timeframe: Up to approximately 1 month
Number of participants with serious adverse events (SAEs)
Timeframe: Up to approximately 1 month
Number of participants with vital sign abnormalities exceeding predefined thresholds
Timeframe: Up to approximately 1 month
Number of participants with electrocardiogram (ECG) abnormalities
Timeframe: Up to approximately 1 month
Number of participants with physical exam abnormalities
Timeframe: Up to approximately 1 month
Number of participants with clinical laboratory evaluation abnormalities
Timeframe: Up to approximately 1 month
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
- 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
- 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
- Clinical pharmacology of MiamiMiami, United States
- Advanced Pharma CR, LLCMiami, United States
- QPS SpringfieldSpringfield, United States
- Ppd Phase I ClinicAustin, United States
- Related resource (www.bms.com)
- Related resource (www.bmsstudyconnect.com)
- Related resource (www.bms.com)
- Related resource (www.fda.gov)