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

• Status: Completed
• Trial end date: 2017-02-27
• Target enrollment: 0
• Participant gender: Male

Summary

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

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Covance
• Treatments: BMS-986165

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.

• 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.