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