Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants
Completed · Phase 1
Conditions studied: Psoriasis
In brief
An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165
Key facts
- Study ID
- NCT03004768
- Run by
- Bristol-Myers Squibb
- People needed
- 6
- Starts
- 2017-01-26
- Expected to finish
- 2017-02-27
- Last updated by the study team
- 2018-02-12
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Covance Madison Clinical Research Unit — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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