An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.

Official Title
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A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunologic Effects of BMS-986256, and a Relative Bioavailability Study in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986256
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Weight ≥ 50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive at screening Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months before screening Exclusion Criteria: Previous participation in the current study or previous exposure within 6 weeks before study drug administration for non-biologics and 12 weeks before study drug administration for biologics Inability to tolerate oral medication Inability to tolerate venipuncture, or inadequate venous access Other protocol defined inclusion/exclusion criteria could 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose<br>Ascending single doses of BMS-986256 | Drug: BMS-986256<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Multiple Dose<br>Ascending multiple doses of BMS-986256 | Drug: BMS-986256<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Sequential Dose<br>Sequential multiple doses of BMS-986256 | Drug: BMS-986256<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) |  | Up to 46 days | 
| Number of deaths |  | Up to 46 days | 
| Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments |  | Up to 44 days | 
| Number of Adverse Events (AEs) leading to early discontinuation |  | Up to 44 days | 
| Maximum concentration (Cmax) |  | Up to 44 days | 
| Time of maximum concentration (Tmax) |  | Up to 44 days | 
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] |  | Up to 44 days | 
| Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] |  | Up to 44 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal elimination rate constant (kel) |  | Up to 44 days | 
| Terminal elimination half-life (T-half) |  | Up to 44 days | 
| Apparent oral clearance (CL/F) |  | Up to 44 days | 
| Metabolite ratio for AUC(INF) [MR(AUC[INF])] |  | Up to 44 days | 
| Metabolite ratio of Cmax [MR(Cmax)] |  | Up to 44 days | 
| Apparent volume of distribution at terminal phase (Vz/F) |  | Up to 44 days | 
| Plasma concentration immediately prior to dosing (Ctrough) |  | Up to 44 days | 
| Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] |  | Up to 44 days | 
| Accumulation ratio of Ctrough [AR(Ctrough)] |  | Up to 44 days | 
| Accumulation ratio of AUC(TAU) [AR(AUC[TAU])] |  | Up to 44 days | 
| Accumulation ratio of Cmax [AR(Cmax)] |  | Up to 44 days | 
| Metabolite ratio for AUC(TAU) [MR(AUC[TAU])] |  | Up to 44 days |