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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Psoriasis

Treatments

Drug: BMS-986165

Study type

Interventional

Funder types

Industry

Identifiers

IM011-016

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.