Healthy ParticipantsPhase 1NCT05658146
A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
A Phase 1 study testing Mavacamten Capsule 1, Mavacamten Capsule 2 and Mavacamten Capsule 3 in people with Healthy Participants, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of this study is to assess 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 Capsule 1, Mavacamten Capsule 2 and Mavacamten Capsule 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jan 2023to 5 Jul 2023
- 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 kilograms/meter squared (kg/m^2) inclusive, at the screening visit.
- Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1.
- Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.
Who cannot join
- Any significant acute or chronic medical illness.
- Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.
- CYP2C19 poor (*2/*2, *3/*3, or *2/*3) or intermediate (*1/*2, *1/*3, *2/*17) metabolizer, as determined by genotyping during screening.
- Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Local Institution - 0001
Anaheim, California, 92801
Local Institution - 0002
Miami, Florida, 33126
Local Institution - 0003
Springfield, Missouri, 65802
About this study
Official title: An Open-label, Randomized, Single-dose, Three-way Crossover Study to Establish Bioequivalence of 5 mg Mavacamten Capsule 1 and 5 × 1 mg Mavacamten Capsule 2 to 5 mg Mavacamten Capsule 2 in Healthy Participants
The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Mavacamten Capsule 1, Mavacamten Capsule 2, Mavacamten Capsule 3
- Keywords
- Healthy Participants, Mavacamten, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mavacamten Capsule 1Drug
Also called BMS-986427, MYK-461
Specified dose on specified days
Mavacamten Capsule 2Drug
Also called BMS-986427, MYK-461
Specified dose on specified days
Mavacamten Capsule 3Drug
Also called BMS-986427, MYK-461
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Drug: Mavacamten Capsule 1; Drug: Mavacamten Capsule 2; Drug: Mavacamten Capsule 3 |
| Sequence 2 | Experimental | Not described Receives: Drug: Mavacamten Capsule 1; Drug: Mavacamten Capsule 2; Drug: Mavacamten Capsule 3 |
| Sequence 3 | Experimental | Not described Receives: Drug: Mavacamten Capsule 1; Drug: Mavacamten Capsule 2; Drug: Mavacamten Capsule 3 |
| Sequence 4 | Experimental | Not described Receives: Drug: Mavacamten Capsule 1; Drug: Mavacamten Capsule 2; Drug: Mavacamten Capsule 3 |
| Sequence 5 | Experimental | Not described Receives: Drug: Mavacamten Capsule 1; Drug: Mavacamten Capsule 2; Drug: Mavacamten Capsule 3 |
| Sequence 6 | Experimental | Not described Receives: Drug: Mavacamten Capsule 1; Drug: Mavacamten Capsule 2; Drug: Mavacamten Capsule 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax)
Measured: From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
Measured: From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Measured: From Day 1 up to Day 35±2 of each period
Secondary outcomes (9)
Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)]
Measured: From Day 1 to Day 4 of each period
Time of Maximum Observed Serum Concentration (Tmax)
Measured: From Day 1 up to Day 35±2 of each period
Terminal Half-life (T-HALF)
Measured: From Day 1 up to Day 35±2 of each period
Number of Participants with Adverse Events (AEs)
Measured: Up to 35 days post discontinuation of dosing
Number of Participants with Serious Adverse Events (SAEs)
Measured: Up to 35 days post discontinuation of dosing
Number of Participants with Vital Sign Abnormalities
Measured: Up to 35 days post discontinuation of dosing
Number of Participants with Electrocardiograms (ECG) Abnormalities
Measured: Up to 35 days post discontinuation of dosing
Number of Participants with Physical Examination Abnormalities
Measured: Up to 35 days post discontinuation of dosing
Number of Participants with Clinical Laboratory Evaluation Abnormalities
Measured: Up to 35 days post discontinuation of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start6 Jan 2023
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 95 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
- NCT05658146
- Sponsor's protocol ID
- CV027-1052
- Status last verified
- Oct 2023
- First submitted
- 13 Dec 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Three-way Crossover Study to Establish Bioequivalence of 5 mg Mavacamten Capsule 1 and 5 × 1 mg Mavacamten Capsule 2 to 5 mg Mavacamten Capsule 2 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05658146
- Acronym / sponsor ID
- CV027-1052
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, Mavacamten, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 20 Dec 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 assess the effects on the single-dose drug levels of mavacamten in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Mavacamten Capsule 1, Drug: Mavacamten Capsule 2, Drug: Mavacamten Capsule 3 |
| Sequence 2 | Experimental | Drug: Mavacamten Capsule 1, Drug: Mavacamten Capsule 2, Drug: Mavacamten Capsule 3 |
| Sequence 3 | Experimental | Drug: Mavacamten Capsule 1, Drug: Mavacamten Capsule 2, Drug: Mavacamten Capsule 3 |
| Sequence 4 | Experimental | Drug: Mavacamten Capsule 1, Drug: Mavacamten Capsule 2, Drug: Mavacamten Capsule 3 |
| Sequence 5 | Experimental | Drug: Mavacamten Capsule 1, Drug: Mavacamten Capsule 2, Drug: Mavacamten Capsule 3 |
| Sequence 6 | Experimental | Drug: Mavacamten Capsule 1, Drug: Mavacamten Capsule 2, Drug: Mavacamten Capsule 3 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index between 18 and 32 kilograms/meter squared (kg/m^2) inclusive, at the screening visit.
- Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1.
- Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness.
- Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.
- CYP2C19 poor (*2/*2, *3/*3, or *2/*3) or intermediate (*1/*2, *1/*3, *2/*17) metabolizer, as determined by genotyping during screening.
- Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.
- Note: 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 |
|---|---|---|
| Mavacamten Capsule 1Also: BMS-986427, MYK-461Specified dose on specified days | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Mavacamten Capsule 2Also: BMS-986427, MYK-461Specified dose on specified days | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Mavacamten Capsule 3Also: BMS-986427, MYK-461Specified dose on specified days | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Maximum Observed Serum Concentration (Cmax)
Time frame: From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
Time frame: From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Time frame: From Day 1 up to Day 35±2 of each period
9 secondary outcomes
Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)]
Time frame: From Day 1 to Day 4 of each period
Time of Maximum Observed Serum Concentration (Tmax)
Time frame: From Day 1 up to Day 35±2 of each period
Terminal Half-life (T-HALF)
Time frame: From Day 1 up to Day 35±2 of each period
Number of Participants with Adverse Events (AEs)
Time frame: Up to 35 days post discontinuation of dosing
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 35 days post discontinuation of dosing
Number of Participants with Vital Sign Abnormalities
Time frame: Up to 35 days post discontinuation of dosing
Number of Participants with Electrocardiograms (ECG) Abnormalities
Time frame: Up to 35 days post discontinuation of dosing
Number of Participants with Physical Examination Abnormalities
Time frame: Up to 35 days post discontinuation of dosing
Number of Participants with Clinical Laboratory Evaluation Abnormalities
Time frame: Up to 35 days post discontinuation of dosing
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 11 Oct 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
3 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 Capsule 1, Mavacamten Capsule 2 and Mavacamten Capsule 3 in people with Healthy Participants, run by Bristol-Myers Squibb at 3 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 3 inclusion and 5 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 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Serum Concentration (Cmax) (time frame: From Day 1 up to Day 35±2 of each period). 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 11 Oct 2023.