How different BMS-986435 tablets are absorbed and whether food changes absorption
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
Run by Bristol-Myers Squibb · NCT07226817 · Data updated 2026-11-12
This will test whether different tablet versions of BMS-986435 are absorbed differently in healthy adults and whether taking the tablet with food changes absorption.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | November 12, 2025 |
| Main results expected | December 17, 2026 |
| Study ends | December 17, 2026 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07226817 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are healthy adults with body weight ≥45 kg, BMI 18–32 kg/m2, normal clinical exams, and left ventricular ejection fraction ≥60%.
✕Probably not a fit
People with significant medical conditions, abnormal cardiac findings, those outside the specified weight/BMI ranges, pregnant or breastfeeding individuals, or anyone seeking direct therapeutic benefit are unlikely to gain direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 study enrolls healthy adult volunteers to compare the relative bioavailability of multiple test tablet formulations of BMS-986435 against an equal-dose reference tablet. Participants will receive study tablets under controlled conditions and have timed blood samples collected to measure drug concentrations over time. After a formulation is selected, the study will also compare pharmacokinetics when that tablet is taken with and without food. Safety and tolerability will be monitored throughout with vital signs, lab tests, ECGs, and echocardiography.
Why it matters
Potential benefit: If successful, the results could identify a tablet formulation and dosing guidance that produce more reliable absorption, informing future patient dosing.
How similar studies have gone: Formulation and food-effect studies are a common part of drug development and have frequently found meaningful differences in drug absorption for other compounds, though results depend on the specific molecule.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * 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
Where it's running
-
Quotient Miami
Miami, Florida, United States Recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.