Healthy Participants
Conditions
Keywords
BMS-986322, Rosuvastatin, Metformin, Methotrexate
Brief summary
The aim of this study is to assess the effect of coadministration of multiple oral doses of BMS-986322 with rosuvastatin, metformin, and methotrexate in healthy participants.
Interventions
DRUGBMS-986322
Specified dose on specified days
DRUGRosuvastatin
Specified dose on specified days
DRUGMetformin
Specified dose on specified days
DIETARY_SUPPLEMENTGlucose
Specified dose on specified days
DRUGMethotrexate
Specified dose on specified days
DRUGLeucovorin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* In the opinion of the investigator, a healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. * Body mass index (BMI) of 18.0 kilogram (kg)/meter(m)\^2 to 30.0 kg/m\^2, inclusive, and body weight ≥ 50 kg for males and ≥ 45 kg for females, at screening. * A female participant is eligible to participate if she is a woman not of childbearing potential. * Female participants must refrain from donating oocytes during the intervention period and for at least 5 half-lives (5 days) after the last dose of study intervention. * For Parts 1 and 2 participants must be 18 to 60 years of age. * For Part 3 participants must be 18 to 50 years of age.
Exclusion criteria
* Any significant acute or chronic medical illness. * Any major surgery, including any gastrointestinal (GI) surgery, with the exception of appendectomy, within 90 days of study intervention administration. * History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mililitre \[mL\] of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%). * Participant must not have a known or suspected immune-mediated disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status. * Participant must not have any history or risk for tuberculosis (TB) in participants with current clinical, radiographic, or laboratory evidence of active TB. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 21 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 21 days |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Up to 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 51 days |
| Number of participants with vital sign abnormalities | Up to 51 days |
| Time of maximum observed plasma concentration (Tmax) | Up to 21 days |
| Number of participants with physical examination abnormalities | Up to 51 days |
| Number of participants with clinical laboratory abnormalities | Up to 51 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 51 days |
| Apparent terminal phase half-life (T-HALF) | Up to 21 days |
| Apparent total body clearance (CLT/F) | Up to 21 days |
Countries
United States
Outcome results
None listed