Psoriasis
Conditions
Brief summary
An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165
Interventions
DRUGBMS-986165
Oral solution dose of 24 mg \[14C\] BMS-986165 containing approximately 100 micro Ci of TRA
Sponsors
Covance
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK apparent volume of distribution (Vz/F) | Day 1 to Day 13 |
| PK apparent total body clearance (CL/F) | Day 1 to Day 13 |
| The primary endpoint is PK exposure that will be determined from plasma concentration versus time | Day 1 to Day 13 |
| Urinary/fecal TRA (Total radioactivity) recovery data | Day 1 to Day 13 |
| PK terminal elimination half-life data (T-HALF) | Day 1 to Day 13 |
| PK time of maximum observed plasma concentration (Tmax) | Day 1 to Day 13 |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints include the incidence of adverse events (AEs) | Day 1 to Day 13 |
| Safety endpoints include the results of electrocardiogram tests (ECGs) | Day 1 to Day 13 |
| Safety endpoints include the results of vital signs | Day 1 to Day 13 |
| Safety endpoints include the results of physical exams | Day 1 to Day 13 |
| Safety endpoints include the results of clinical laboratory tests | Day 1 to Day 13 |
Countries
United States
Outcome results
None listed