Healthy Participants
Conditions
Brief summary
This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.
Interventions
DRUGFluconazole
Specified Dose on Specified Days
DRUGBupropion
Specified Dose on Specified Days
DRUGItraconazole
Specified Dose on Specified Days
DRUGBMS-986235
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening. * Males and females must agree to follow specific methods of contraception, if applicable. * Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations, and no significant findings in medical history.
Exclusion criteria
* Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding * Inability to tolerate oral medication * Known previous exposure to BMS-986235. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole | Day 12 |
| Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole | Day 12 |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole | Day 12 |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion | Day 13 |
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion | Day 13 |
| Maximum plasma concentration (Cmax) of BMS-986235 with bupropion | Day 13 |
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole | Day 9 |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole | Day 9 |
| Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole | Day 9 |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 | Day 1 |
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 | Day 1 |
| Maximum plasma concentration (Cmax) of BMS-986235 | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Number of clinically significant changes in electrocardiogram (ECG) | Up to 44 days |
| Incidence of Nonserious Adverse Events (AEs) | Up to 49 days |
| Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2)) | Up to 44 days |
| Incidence of Serious Adverse Events (SAEs) | Up to 77 days |
| Incidence of AEs leading to discontinuation | Up to 16 days |
| Number of clinically significant changes from baseline in vital signs: Body Temperature | Up to 44 days |
| Number of clinically significant changes from baseline in physical examinations | Up to 44 days |
| Number of clinically significant changes in clinical laboratory tests: Hematology | Up to 44 days |
| Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry | Up to 44 days |
| Number of clinically significant changes in clinical laboratory tests: Coagulation | Up to 44 days |
| Number of clinically significant changes in clinical laboratory tests: Urinalysis | Up to 44 days |
| Number of clinically significant changes from baseline in vital signs: Respiratory Rate | Up to 44 days |
| Number of clinically significant changes from baseline in vital signs: Heart Rate | Up to 44 days |
| Number of clinically significant changes from baseline in vital signs:Blood Pressure | Up to 44 days |
Countries
United States
Outcome results
None listed