Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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.

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, 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.