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Recruiting NCT07226817

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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986435.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 Formulation (Part 3) in Healthy Adult Participants

Overview

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 selected BMS-986435 tablet formulation will also be evaluated.

Interventions

  • Drug BMS-986435
    Specified dose on specified days

Primary outcome measures

  • Maximum observed concentration (Cmax) [Time frame: Up to Day 28]
  • Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Time frame: Up to Day 28]
  • Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Time frame: Up to Day 28]
Secondary outcome measures (11)
  • Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h)) [Time frame: Up to Day 28]
  • Time of maximum observed concentration (Tmax) [Time frame: Up to Day 28]
  • Half-life (T-HALF) [Time frame: Up to Day 28]
  • Apparent total body clearance (CLT/F) [Time frame: Up to Day 28]
  • Volume of distribution of terminal phase (Vz/F) [Time frame: Up to Day 28]
  • Number of participants with Adverse Events (AEs) [Time frame: Up to Day 35]
  • Number of participants with Serious AEs (SAEs) [Time frame: Up to Day 35]
  • Number of participants with clinical laboratory abnormalities [Time frame: Up to Day 28]
  • Number of participants with vital sign abnormalities [Time frame: Up to Day 28]
  • Number of participants with physical examination abnormalities [Time frame: Up to Day 28]
  • Number of participants with electrocardiogram (ECG) abnormalities [Time frame: Up to Day 28]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Quotient Miami — Miami

Identifiers

NCT: NCT07226817 · CV029-1024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗