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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Miami, Florida, United States
Maximum observed plasma concentration (Cmax)
Parts 1 and 2
Time frame: Up to 53 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Parts 1 and 2
Time frame: Up to 53 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Parts 1 and 2
Time frame: Up to 53 days
Time to attain maximum observed plasma concentration (Tmax)
Parts 1 and 2
Time frame: Up to 53 days
Terminal half-life (T-Half)
Parts 1 and 2
Time frame: Up to 53 days
Apparent total body clearance of the drug from the plasma (CLT/F)
Parts 1 and 2
Time frame: Up to 53 days
Number of participants with adverse events (AEs)
Parts 1 and 2
Time frame: Up to 124 days
Number of participants with clinical laboratory abnormalities
Parts 1 and 2
Time frame: Up to 66 days
Number of participants with physical examination abnormalities
Parts 1 and 2
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Time frame: Up to 66 days
Number of participants with vital sign abnormalities
Parts 1 and 2
Time frame: Up to 66 days
Number of participants with electrocardiogram (ECG) abnormalities
Parts 1 and 2
Time frame: Up to 66 days