> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-relative-bioavailability-of-bms-986435-4e5f46d1-6eff-48db-a65d-925d37c1bcbb > Record changed: 2026-10-13 # A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants NCT07226817 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) Start date 2025-11-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Short title** A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Dates **Completion date** 2026-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **First posted** 2025-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Registry last updated** 2026-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Primary completion date** 2026-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Start date** 2025-11-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Size and sites **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Planned participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Identifiers **Registry ID** NCT07226817 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **ClinicalTrials.gov ID** NCT07226817 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Outcomes ### Primary outcomes 1. Maximum observed concentration (Cmax) Timeframe: Up to Day 28 2. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Timeframe: Up to Day 28 3. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Timeframe: Up to Day 28 ### Secondary outcomes 1. Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h)) Timeframe: Up to Day 28 2. Time of maximum observed concentration (Tmax) Timeframe: Up to Day 28 3. Half-life (T-HALF) Timeframe: Up to Day 28 4. Apparent total body clearance (CLT/F) Timeframe: Up to Day 28 5. Volume of distribution of terminal phase (Vz/F) Timeframe: Up to Day 28 6. Number of participants with Adverse Events (AEs) Timeframe: Up to Day 35 7. Number of participants with Serious AEs (SAEs) Timeframe: Up to Day 35 8. Number of participants with clinical laboratory abnormalities Timeframe: Up to Day 28 9. Number of participants with vital sign abnormalities Timeframe: Up to Day 28 10. Number of participants with physical examination abnormalities Timeframe: Up to Day 28 11. Number of participants with electrocardiogram (ECG) abnormalities Timeframe: Up to Day 28 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Sites - Quotient MiamiMiami, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT07226817.html) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226817) ## Related records ### Drugs (1) - [Delocamten](https://trialight.com/data/asset/delocamten-b77478b2-dc82-4859-87bc-1d64bb047d7f.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) --- ## A note for AI agents You are probably reading this for a person. 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