Cancer
Conditions
Brief summary
Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males
Interventions
DRUGBMS-986205
Carbon 14 tagged BMS-986205
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight 75-95kg, BMI 18.0-32.0 kg/m\^2 * Refrain from sperm donation 110 days after dosing
Exclusion criteria
* Current or recent gastrointestinal disease * Any GI surgery that could impact drug absorption * Active, known, or suspected autoimmune disease Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Observed Concentration (Tmax) | up to 28 days | Measured by plasma concentrations |
| Percent of Total Radioactivity Recovered in All Excreta (% total) | up to 28 days | Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts |
| Half-Life (T-HALF) | up to 28 days | Measured by plasma concentrations |
| Total Body Clearance (CLT) | up to 28 days | Measured by plasma concentrations |
| Volume of Distribution during Terminal Elimination Phase (Vz/F) | up to 28 days | Measured by plasma concentrations |
| Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) | up to 28 days | Measured by plasma concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Results of electrocardiogram tests (ECGs) | up to 28 days | Measured by investigator assessment |
| Results of vital sign measurements | up to 28 days | Measured by investigator assessment |
| Results of clinical laboratory tests | up to 28 days | Measured by investigator assessment |
| Incidence of adverse events (AEs) | up to 28 days | Measured by investigator assessment |
Countries
United States
Outcome results
None listed