Healthy VolunteersPhase 1NCT07226817
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
A Phase 1 study testing BMS-986435 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the drug levels of selected BMS-986435 tablet formulations will also be evaluated. 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?
- BMS-986435
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 17 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg/m2, inclusive
- Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments
- Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment
- Other protocol-defined Inclusion/Exclusion criteria apply
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
United States1 site, 1 recruiting
- Recruiting
Quotient Miami
Miami, Florida, 33126
Juliet Vento, Site 0001
About this study
Official title: A Phase 1, Open-label, Single-site, Multi-part, Non-randomized, Parallel-group Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations (Parts 1 & 2) and Food Effect on the Selected BMS-986435 Tablet Formulations (Part 3) in Healthy Adult Participants
This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the drug levels of selected BMS-986435 tablet formulations will also be evaluated.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986435
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986435Drug
Also called MYK-224
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment B | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment C | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment D | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment E | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment F | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment G | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment H | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment I | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment J | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment K | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment L | Experimental | Not described Receives: Drug: BMS-986435 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to Day 28
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 28
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 28
Secondary outcomes (11)
Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h))
Measured: Up to Day 28
Time of maximum observed concentration (Tmax)
Measured: Up to Day 28
Half-life (T-HALF)
Measured: Up to Day 28
Apparent total body clearance (CLT/F)
Measured: Up to Day 28
Volume of distribution of terminal phase (Vz/F)
Measured: Up to Day 28
Number of participants with Adverse Events (AEs)
Measured: Up to Day 35
Number of participants with Serious AEs (SAEs)
Measured: Up to Day 35
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 28
Number of participants with vital sign abnormalities
Measured: Up to Day 28
Number of participants with physical examination abnormalities
Measured: Up to Day 28
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start12 Nov 2025
- Primary completion17 Dec 2026 (estimated)
- Study completion17 Dec 2026 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
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
- NCT07226817
- Sponsor's protocol ID
- CV029-1024
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-site, Multi-part, Non-randomized, Parallel-group Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations (Parts 1 & 2) and Food Effect on the Selected BMS-986435 Tablet Formulations (Part 3) in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07226817
- Acronym / sponsor ID
- CV029-1024
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 17 Dec 2026 (estimated)
- First posted
- 10 Nov 2025 (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.
This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the drug levels of selected BMS-986435 tablet formulations will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: BMS-986435 |
| Treatment B | Experimental | Drug: BMS-986435 |
| Treatment C | Experimental | Drug: BMS-986435 |
| Treatment D | Experimental | Drug: BMS-986435 |
| Treatment E | Experimental | Drug: BMS-986435 |
| Treatment F | Experimental | Drug: BMS-986435 |
| Treatment G | Experimental | Drug: BMS-986435 |
| Treatment H | Experimental | Drug: BMS-986435 |
| Treatment I | Experimental | Drug: BMS-986435 |
| Treatment J | Experimental | Drug: BMS-986435 |
| Treatment K | Experimental | Drug: BMS-986435 |
| Treatment L | Experimental | Drug: BMS-986435 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg/m2, inclusive
- Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments
- Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment
- Other protocol-defined Inclusion/Exclusion criteria apply
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BMS-986435Also: MYK-224Specified dose on specified days | Drug | Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F, Treatment G, Treatment H, Treatment I, Treatment J, Treatment K, Treatment L |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to Day 28
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 28
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 28
11 secondary outcomes
Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h))
Time frame: Up to Day 28
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 28
Half-life (T-HALF)
Time frame: Up to Day 28
Apparent total body clearance (CLT/F)
Time frame: Up to Day 28
Volume of distribution of terminal phase (Vz/F)
Time frame: Up to Day 28
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 35
Number of participants with Serious AEs (SAEs)
Time frame: Up to Day 35
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 28
Number of participants with vital sign abnormalities
Time frame: Up to Day 28
Number of participants with physical examination abnormalities
Time frame: Up to Day 28
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
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 BMS-986435 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 4 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) (time frame: Up to Day 28). 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 12 Aug 2026.