Healthy Male Volunteers
Conditions
Brief summary
Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine
Interventions
DRUGBMS-986165
Oral administration of tablet BMS- 986165
DRUGPyrimethamine
Oral administration of Pyrimethamine in combination with BMS-986185
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients must be willing and able to complete all study-specific procedures and visits * Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations * Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening * Normal renal function at screening
Exclusion criteria
* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease * Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug * History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed serum comcentration (Cmax) | Day 1, Day 5 |
| Area under the concentration-time curve from time zero extrapolated to AUC(INF) | Day 1, Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Half- life time (T-Half) | Day 1, Day 5 |
| Apparent oral clearance (CL/F) | Day 5 |
| Incidences of Adverse Events (AE's) | Approximetly 20 days |
| Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T) | Day 5 |
| Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF) | Day 5 |
| Apparent volume of distribution at terminal phase (Vz/F) | Day 5 |
| Time of maximum observed concentration (Tmax) | Approxmiately 20 days |
Countries
United States
Outcome results
None listed