A Study of BMS-986195 in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.

Official Title
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Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: BMS-986195


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: Male subjects, if not surgically sterilized, must agree to use adequate contraception Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator Exclusion Criteria: Previous participation in the current study Known previous exposure to BMS-986195 Employee of PRA or the Sponsor History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products Using tobacco products within 60 days prior to drug administration Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies 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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Male

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986195<br>A single oral solution dose of BMS-986195 | Drug: BMS-986195<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 |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to 16 days | 
| Time to attain maximum observed plasma concentration (tmax) |  | Up to 16 days | 
| Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)] |  | Up to 16 days | 
| Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)] |  | Up to 16 days | 
| Percentage of estimated part for the calculation of AUC0-inf (%AUCextra) |  | Up to 16 days | 
| Terminal elimination rate constant (kel) |  | Up to 16 days | 
| Terminal elimination half life, calculated as 0.693/kel (t1/2) |  | Up to 16 days | 
| Apparent oral clearance, calculated as dose/AUC0-inf (CL/F) |  | Up to 16 days | 
| Apparent volume of distribution at terminal phase (Vz/F) |  | Up to 16 days | 
| Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%) |  | Up to 16 days | 
| Ratio of AUC0-inf of plasma TRA relative to blood TRA (%) |  | Up to 16 days | 
| Cumulative amount of TRA excreted in urine (Aeurine) |  | Up to 16 days | 
| Cumulative amount of TRA excreted in feces (Aefeces) |  | Up to 16 days | 
| Cumulative amount of TRA excreted in bile (Aebile) |  | Up to 16 days | 
| Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces |  | Up to 16 days | 
| Fraction of the dose administered excreted in urine (feurine) |  | Up to 16 days | 
| Fraction of the dose administered excreted in feces (fefeces) |  | Up to 16 days | 
| Fraction of the dose administered excreted in bile (febile) |  | Up to 16 days | 
| Fraction of the dose administered excreted in urine and feces (fetotal) |  | Up to 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AE) |  | Up to 16 days | 
| Number of serious adverse events (SAE) |  | Up to 16 days | 
| Number of laboratory test result abnormalities |  | Up to 16 days | 
| Heart rate measured by ECG |  | Up to 16 days | 
| PR-interval measured by ECG |  | Up to 16 days | 
| QRS-duration measured by ECG |  | Up to 16 days | 
| QT-interval measured by ECG |  | Up to 16 days | 
| QTc-interval (Fridericia's) measured by ECG |  | Up to 16 days |