Healthy ParticipantsPhase 1NCT06577259
Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants
A Phase 1 study testing BMS-986435 in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female 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?
- BMS-986435
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to 19 Feb 2025
- 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 weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m^2, inclusive.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
- Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.
Who cannot join
- Any acute or chronic medical illness.
- History of heart disease.
- Prior exposure to BMS-986435.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-site, Randomized, Single-dose, Three-way, Crossover Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations in Healthy Adult Participants
The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986435
- Keywords
- BMS-986435, MYK-224, Healthy participants, Single-dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986435Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: BMS-986435 Reference Dose 1 | Active comparator | Not described Receives: Drug: BMS-986435 |
| Treatment B: BMS-986435 Test Dose 1 | Experimental | Not described Receives: Drug: BMS-986435 |
| Treatment C: BMS-986435 Test Dose 2 | 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 plasma concentration (Cmax)
Measured: Up to 105 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Measured: Up to 105 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Measured: Up to 105 days
Secondary outcomes (9)
Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)]
Measured: Up to 105 days
Time of maximum observed concentration [Tmax]
Measured: Up to 105 days
Apparent terminal half-life [T-HALF]
Measured: Up to 105 days
Incidence of adverse events (AEs)
Measured: Up to approximately 5 months
Incidence of serious adverse events (SAEs)
Measured: Up to approximately 5 months
Incidence of participants with vital sign abnormalities
Measured: Up to 105 days
Incidence of participants with physical examinations abnormalities
Measured: Up to 105 days
Incidence of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 105 days
Incidence of participants with clinical laboratory abnormalities
Measured: Up to 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start3 Sep 2024
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
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
- 25 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
- NCT06577259
- Sponsor's protocol ID
- CV029-1018
- Status last verified
- Mar 2025
- First submitted
- 27 Aug 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-site, Randomized, Single-dose, Three-way, Crossover Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06577259
- Acronym / sponsor ID
- CV029-1018
- Conditions
- Healthy Participants
- Keywords
- BMS-986435, MYK-224, Healthy participants, Single-dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 29 Aug 2024 (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 relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: BMS-986435 Reference Dose 1 | Active comparator | Drug: BMS-986435 |
| Treatment B: BMS-986435 Test Dose 1 | Experimental | Drug: BMS-986435 |
| Treatment C: BMS-986435 Test Dose 2 | Experimental | Drug: BMS-986435 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m^2, inclusive.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
- Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.
Key exclusion criteria (4 listed)
- Any acute or chronic medical illness.
- History of heart disease.
- Prior exposure to BMS-986435.
- 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 |
|---|---|---|
| BMS-986435Specified dose on specified days | Drug | Treatment A: BMS-986435 Reference Dose 1, Treatment B: BMS-986435 Test Dose 1, Treatment C: BMS-986435 Test Dose 2 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 105 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Time frame: Up to 105 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to 105 days
9 secondary outcomes
Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)]
Time frame: Up to 105 days
Time of maximum observed concentration [Tmax]
Time frame: Up to 105 days
Apparent terminal half-life [T-HALF]
Time frame: Up to 105 days
Incidence of adverse events (AEs)
Time frame: Up to approximately 5 months
Incidence of serious adverse events (SAEs)
Time frame: Up to approximately 5 months
Incidence of participants with vital sign abnormalities
Time frame: Up to 105 days
Incidence of participants with physical examinations abnormalities
Time frame: Up to 105 days
Incidence of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 105 days
Incidence of participants with clinical laboratory abnormalities
Time frame: Up to 105 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 14 Mar 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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/disclosurecommitment.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. 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 BMS-986435 in people with Healthy Participants, 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 3 inclusion and 4 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 14 Mar 2025. 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 105 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 14 Mar 2025.