Healthy Volunteers
Conditions
Keywords
healthy, pharmacokinetics, BMS-986419
Brief summary
The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.
Interventions
DRUGBMS-986419
Specified dose on specified days
DRUGCaffeine
Specified dose on specified days
DRUGBupropion
Specified dose on specified days
DRUGFlurbiprofen
Specified dose on specified days
DRUGOmeprazole
Specified dose on specified days
DRUGMidazolam
Specified dose on specified days
DRUGFexofenadine
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in (Day -1). * Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.
Exclusion criteria
* Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator * Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 25 |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 25 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 25 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events (AEs) | Up to 28 days after last dose |
| Number of participants with Serious Adverse Events (SAEs) | Up to 28 days after last dose |
| Number of participants with AEs leading to discontinuation | Up to 28 days after last dose |
| Number of participants with vital sign abnormalities | Up to Day 25 |
| Maximum observed plasma concentration (Cmax) | Up to Day 25 |
| Number of participants with physical examination abnormalities | Up to Day 25 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 25 |
| Number of participants with clinical laboratory abnormalities | Up to Day 25 |
| Number of participants with 12-lead ECG assessment abnormalities | Up to Day 25 |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 25 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 25 |
Countries
United States
Outcome results
None listed