Healthy ParticipantsPhase 1NCT05362045
A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
A Phase 1 study testing Mavacamten in people with Healthy Participants, run by Bristol-Myers Squibb at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Mavacamten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 May 2022to 19 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Ppd Phase I Clinic
Austin, Texas, 78744
Clinical pharmacology of Miami
Miami, Florida, 33014
Advanced Pharma CR, LLC
Miami, Florida, 33147
QPS Springfield
Springfield, Missouri, 65802
About this study
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
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Mavacamten
- Keywords
- Mavacamten, Healthy Participants, Bioequivalence, Hypertrophic Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
Also called BMS-986427, MYK-461
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Mavacamten- Dose A | Experimental | Not described Receives: Drug: Mavacamten |
| Mavacamten- Dose B | Experimental | Not described Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: 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))
Measured: Up to approximately 1 month
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Measured: Up to approximately 1 month
Secondary outcomes (8)
Time of maximum observed plasma concentration (Tmax)
Measured: Up to approximately 1 month
Terminal half-life (T-HALF)
Measured: Up to approximately 1 month
Number of participants with adverse events (AEs)
Measured: Up to approximately 1 month
Number of participants with serious adverse events (SAEs)
Measured: Up to approximately 1 month
Number of participants with vital sign abnormalities exceeding predefined thresholds
Measured: Up to approximately 1 month
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to approximately 1 month
Number of participants with physical exam abnormalities
Measured: Up to approximately 1 month
Number of participants with clinical laboratory evaluation abnormalities
Measured: Up to approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start16 May 2022
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362045
- Sponsor's protocol ID
- CV027-070
- Status last verified
- Nov 2022
- First submitted
- 2 May 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05362045
- Acronym / sponsor ID
- CV027-070
- Conditions
- Healthy Participants
- Keywords
- Mavacamten, Healthy Participants, Bioequivalence, Hypertrophic Cardiomyopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mavacamten- Dose A | Experimental | Drug: Mavacamten |
| Mavacamten- Dose B | Experimental | Drug: Mavacamten |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MavacamtenAlso: BMS-986427, MYK-461Specified dose on specified days | Drug | Mavacamten- Dose A, Mavacamten- Dose B |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: 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))
Time frame: Up to approximately 1 month
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Time frame: Up to approximately 1 month
8 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to approximately 1 month
Terminal half-life (T-HALF)
Time frame: Up to approximately 1 month
Number of participants with adverse events (AEs)
Time frame: Up to approximately 1 month
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 1 month
Number of participants with vital sign abnormalities exceeding predefined thresholds
Time frame: Up to approximately 1 month
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to approximately 1 month
Number of participants with physical exam abnormalities
Time frame: Up to approximately 1 month
Number of participants with clinical laboratory evaluation abnormalities
Time frame: Up to approximately 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mavacamten in people with Healthy Participants, run by Bristol-Myers Squibb at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Up to approximately 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.