Healthy Participants
Conditions
Keywords
BMS-986256, Afimetoran, Midazolam, CYP3A4, Phenytoin
Brief summary
This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).
Interventions
DRUGAfimetoran
Specified dose on specified days
DRUGPhenytoin
Specified dose on specified days
DRUGMidazolam
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) of 19.0 kilograms per meter squared (kg/m\^2) to 32.0 kg/m2, inclusive, and body weight ≥ 55 kg, at screening.
Exclusion criteria
* Any significant acute or chronic medical illness or any other condition listed as a contraindication in the phenytoin (Part 1) or midazolam (Part 2) package inserts. * History of seizure (including simple febrile seizure), epilepsy, severe head injury (including concussion), multiple sclerosis, or other known neurological condition which the investigator considers to be clinically significant. * Current or recent (within 3 months of study intervention administration) GI disease that could impact upon the absorption of study intervention. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 53 days | Parts 1 and 2 |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) | Up to 53 days | Parts 1 and 2 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 53 days | Parts 1 and 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 124 days | Parts 1 and 2 |
| Number of participants with clinical laboratory abnormalities | Up to 66 days | Parts 1 and 2 |
| Time to attain maximum observed plasma concentration (Tmax) | Up to 53 days | Parts 1 and 2 |
| Number of participants with vital sign abnormalities | Up to 66 days | Parts 1 and 2 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 66 days | Parts 1 and 2 |
| Number of participants with physical examination abnormalities | Up to 66 days | Parts 1 and 2 |
| Terminal half-life (T-Half) | Up to 53 days | Parts 1 and 2 |
| Apparent total body clearance of the drug from the plasma (CLT/F) | Up to 53 days | Parts 1 and 2 |
Countries
United States
Outcome results
None listed