A Study of Experimental Medication BMS-986235 in Healthy Subjects

Study Overview
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Brief Summary
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This is a study of experimental medication BMS-986235 in healthy subjects.

Official Title
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Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986235 in Healthy Subjects

Conditions
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Mediators of Inflammation

Intervention / Treatment
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* Drug: BMS-986235
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive Exclusion Criteria: Patients that are pregnant Patient with any significant acute or chronic medical illness Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption Patient with any surgery within 12 weeks of study treatment administration Patient with any gastrointestinal surgery that could impact upon the absorption of study drug Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only) Patient who received a blood transfusion within 12 weeks of study drug administration Other protocol defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single ascending dose (SAD): BMS-986235 or Placebo<br>BMS-986235 or Placebo oral dose | Drug: BMS-986235<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Multiple ascending dose (MAD): BMS-986235 or Placebo<br>BMS-986235 or Placebo oral dose | Drug: BMS-986235<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events (SAE) |  | Approximately 30 days | 
| Number of deaths |  | Approximately 30 days | 
| Number of adverse events (AE) leading to study discontinuation |  | Approximately 30 days | 
| Number of patients with clinically significant changes in ECG parameters, as defined by the investigator |  | Approximately 30 days | 
| Number of patients with potentially clinically significant changes in vital signs |  | Approximately 30 days |