This is an open-label, single-dose, study in healthy males. The primary objective is to
assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral dose
of radiolabeled BMS-986142 in healthy male subjects.
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Locations near you
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Full eligibility criteria for NCT02880670
Ages eligible for Study
18 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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, or 30 days after the last dose of study drug.
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.
History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
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.
All locations for NCT02880670
United States (1)
Madison, Wisconsin, United States, 53704
View full eligibility
Tris trial is registered with FDA with number: NCT02880670. The sponsor of the trial is Bristol-Myers Squibb and it is looking for 9 volunteers for the current phase.
Official trial title: Pharmacokinetics and Metabolism of [14C] BMS-986142 in Healthy Male Subjects
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