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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 50
Updated:2/14/2018
Start Date:January 26, 2017
End Date:February 27, 2017

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


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.
We found this trial at
1
site
Madison, Wisconsin 53704
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from
Madison, WI
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