Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants

Study Overview
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Brief Summary
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An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165

Official Title
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Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: BMS-986165


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2. No evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination Exclusion Criteria: History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population. Participant with greater than Grade 2 acne. Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Single dose of radiolabeled BMS-986165<br> | Drug: BMS-986165<br>* Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is PK exposure that will be determined from plasma concentration versus time |  | Day 1 to Day 13 | 
| Urinary/fecal TRA (Total radioactivity) recovery data |  | Day 1 to Day 13 | 
| PK terminal elimination half-life data (T-HALF) |  | Day 1 to Day 13 | 
| PK apparent total body clearance (CL/F) |  | Day 1 to Day 13 | 
| PK apparent volume of distribution (Vz/F) |  | Day 1 to Day 13 | 
| PK time of maximum observed plasma concentration (Tmax) |  | Day 1 to Day 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints include the incidence of adverse events (AEs) |  | Day 1 to Day 13 | 
| Safety endpoints include the results of electrocardiogram tests (ECGs) |  | Day 1 to Day 13 | 
| Safety endpoints include the results of vital signs |  | Day 1 to Day 13 | 
| Safety endpoints include the results of physical exams |  | Day 1 to Day 13 | 
| Safety endpoints include the results of clinical laboratory tests |  | Day 1 to Day 13 |