A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants

NCT07226817
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
240
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Lead sponsor
Bristol-Myers Squibb
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Start date
2025-11-12
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Number of sites
1
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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.
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Short title
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-12-17
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First posted
2025-11-10
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Registry last updated
2026-08-12
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Primary completion date
2026-12-17
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Start date
2025-11-12
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Participants
240
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Participant count basis
Estimated
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Planned participants
240
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Protocol amendments
2
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07226817
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ClinicalTrials.gov ID
NCT07226817
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
Yes

  • 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
clinicaltrials.gov

  • Quotient MiamiMiami, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Sources for references
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Related records

Drugs (1)

Lead sponsors (1)