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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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

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

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

United States1 site, 1 recruiting

  • Quotient Miami

    Miami, Florida, 33126

    Juliet Vento, Site 0001

    Recruiting

Other trials in United States

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.

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 groups in NCT07226817
Study groupRoleWhat they receive
Treatment AExperimentalNot described
Receives: Drug: BMS-986435
Treatment BExperimentalNot described
Receives: Drug: BMS-986435
Treatment CExperimentalNot described
Receives: Drug: BMS-986435
Treatment DExperimentalNot described
Receives: Drug: BMS-986435
Treatment EExperimentalNot described
Receives: Drug: BMS-986435
Treatment FExperimentalNot described
Receives: Drug: BMS-986435
Treatment GExperimentalNot described
Receives: Drug: BMS-986435
Treatment HExperimentalNot described
Receives: Drug: BMS-986435
Treatment IExperimentalNot described
Receives: Drug: BMS-986435
Treatment JExperimentalNot described
Receives: Drug: BMS-986435
Treatment KExperimentalNot described
Receives: Drug: BMS-986435
Treatment LExperimentalNot described
Receives: Drug: BMS-986435

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed concentration (Cmax)

    Measured: Up to Day 28

  2. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Measured: Up to Day 28

  3. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Measured: Up to Day 28

Secondary outcomes (11)

  1. Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h))

    Measured: Up to Day 28

  2. Time of maximum observed concentration (Tmax)

    Measured: Up to Day 28

  3. Half-life (T-HALF)

    Measured: Up to Day 28

  4. Apparent total body clearance (CLT/F)

    Measured: Up to Day 28

  5. Volume of distribution of terminal phase (Vz/F)

    Measured: Up to Day 28

  6. Number of participants with Adverse Events (AEs)

    Measured: Up to Day 35

  7. Number of participants with Serious AEs (SAEs)

    Measured: Up to Day 35

  8. Number of participants with clinical laboratory abnormalities

    Measured: Up to Day 28

  9. Number of participants with vital sign abnormalities

    Measured: Up to Day 28

  10. Number of participants with physical examination abnormalities

    Measured: Up to Day 28

  11. 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.

  1. First posted10 Nov 2025
  2. Study start12 Nov 2025
  3. Primary completion17 Dec 2026 (estimated)
  4. Study completion17 Dec 2026 (estimated)

Resources

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)
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

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