Healthy VolunteersPhase 1NCT05405543
A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese Participants
A Phase 1 study testing MYK-224 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of both single and multiple dose drug levels of MYK-224 in healthy adult Japanese 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 Volunteers
- What is being tested?
- MYK-224
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 9 Dec 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
- Healthy as determined by medical history, physical examination, vital signs,12-lead electrocardiogram and routine laboratory assessments
- Must have documented left Ventricular Ejection Fraction (LVEF) ≥60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.
Who cannot join
- Any acute or chronic medical illness
- History of heart disease
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of MYK-224 in Healthy Adult Japanese Participants
The purpose of this study is to evaluate the effects of both single and multiple dose drug levels of MYK-224 in healthy adult Japanese participants.
- Conditions
- Healthy Volunteers
- Being tested
- MYK-224, Placebo
- Keywords
- MYK-224, Healthy Participants of Japanese Ethnicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYK-224Drug
Also called BMS-986435
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: MYK-224; Other: Placebo |
| Arm 2 | Experimental | Not described Receives: Drug: MYK-224; Other: Placebo |
| Arm 3 | Experimental | Not described Receives: Drug: MYK-224; Other: Placebo |
| Arm 4 | Experimental | Not described Receives: Drug: MYK-224; Other: Placebo |
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 72 days
Time of maximum observed concentration (Tmax)
Measured: Up to 72 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Measured: Up to 72 days
Secondary outcomes (26)
Number of participants with adverse events (AEs)
Measured: Up to 130 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 130 days
Number of participants with adverse events leading to discontinuation
Measured: Up to 130 days
Number of participants with vital sign abnormalities
Measured: Up to 72 days
Number of participants with physical exam abnormalities
Measured: Up to 72 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 72 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 72 days
Measurement of left ventricular ejection fraction (LVEF)
Measured: Up to 72 days
Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
Measured: Up to 72 days
Measurement of left ventricular fractional shortening (LVFS)
Measured: Up to 72 days
Measurement of left ventricular global longitudinal strain (LV GLS)
Measured: Up to 72 days
Measurement of left ventricle stroke volume (LVSV)
Measured: Up to 72 days
Measurement of lateral and septal early diastolic mitral annular velocity (e')
Measured: Up to 72 days
Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')
Measured: Up to 72 days
Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)
Measured: Up to 72 days
Measurement of left ventricular (LV) mass index
Measured: Up to 72 days
Measurement of left atrial volume index
Measured: Up to 72 days
Measurement of interventricular septal thickness
Measured: Up to 72 days
Measurement of posterior wall thickness
Measured: Up to 72 days
Measurement of LV end diastolic volume
Measured: Up to 72 days
Measurement of LV end diastolic volume index
Measured: Up to 72 days
Measurement of LV end systolic volume
Measured: Up to 72 days
Measurement of LV end systolic volume index
Measured: Up to 72 days
Relative bioavailability of test formulation compared to the reference formulation based on Cmax
Measured: Up to 72 days
Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T)
Measured: Up to 72 days
Relative bioavailability of test forumulation compared to the reference formulation based on area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Measured: Up to 72 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start12 Jul 2022
- Primary completion16 Nov 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT05405543
- Sponsor's protocol ID
- CV029-014
- Status last verified
- Jan 2023
- First submitted
- 1 Jun 2022
- Last updated
- 13 Jan 2023
- 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 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of MYK-224 in Healthy Adult Japanese Participants
- ClinicalTrials.gov ID
- NCT05405543
- Acronym / sponsor ID
- CV029-014
- Conditions
- Healthy Volunteers
- Keywords
- MYK-224, Healthy Participants of Japanese Ethnicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 6 Jun 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 of both single and multiple dose drug levels of MYK-224 in healthy adult Japanese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: MYK-224, Other: Placebo |
| Arm 2 | Experimental | Drug: MYK-224, Other: Placebo |
| Arm 3 | Experimental | Drug: MYK-224, Other: Placebo |
| Arm 4 | Experimental | Drug: MYK-224, Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy as determined by medical history, physical examination, vital signs,12-lead electrocardiogram and routine laboratory assessments
- Must have documented left Ventricular Ejection Fraction (LVEF) ≥60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.
Key exclusion criteria (3 listed)
- Any acute or chronic medical illness
- History of heart disease
- 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 |
|---|---|---|
| MYK-224Also: BMS-986435Specified dose on specified days | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| PlaceboSpecified dose on specified days | Other | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 72 days
Time of maximum observed concentration (Tmax)
Time frame: Up to 72 days
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 72 days
26 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 130 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 130 days
Number of participants with adverse events leading to discontinuation
Time frame: Up to 130 days
Number of participants with vital sign abnormalities
Time frame: Up to 72 days
Number of participants with physical exam abnormalities
Time frame: Up to 72 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 72 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 72 days
Measurement of left ventricular ejection fraction (LVEF)
Time frame: Up to 72 days
Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
Time frame: Up to 72 days
Measurement of left ventricular fractional shortening (LVFS)
Time frame: Up to 72 days
Measurement of left ventricular global longitudinal strain (LV GLS)
Time frame: Up to 72 days
Measurement of left ventricle stroke volume (LVSV)
Time frame: Up to 72 days
Measurement of lateral and septal early diastolic mitral annular velocity (e')
Time frame: Up to 72 days
Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')
Time frame: Up to 72 days
Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)
Time frame: Up to 72 days
Measurement of left ventricular (LV) mass index
Time frame: Up to 72 days
Measurement of left atrial volume index
Time frame: Up to 72 days
Measurement of interventricular septal thickness
Time frame: Up to 72 days
Measurement of posterior wall thickness
Time frame: Up to 72 days
Measurement of LV end diastolic volume
Time frame: Up to 72 days
Measurement of LV end diastolic volume index
Time frame: Up to 72 days
Measurement of LV end systolic volume
Time frame: Up to 72 days
Measurement of LV end systolic volume index
Time frame: Up to 72 days
Relative bioavailability of test formulation compared to the reference formulation based on Cmax
Time frame: Up to 72 days
Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T)
Time frame: Up to 72 days
Relative bioavailability of test forumulation compared to the reference formulation based on area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Time frame: Up to 72 days
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 13 Jan 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Screening Protocol
Pain
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MYK-224 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site 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 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 72 days). 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 13 Jan 2023.