This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Intravenous (IV) administration
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, Hungary
Clinical Research Unit Hungary
Miskolc, Hungary
BioVirtus Centrum Medyczne
Józefów, Poland
KO-MED Centra Kliniczne Lublin
Lublin, Poland
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration
Time frame: Up to 2 days
AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration
Time frame: Up to 2 days
Maximum plasma concentration (Cmax)
Time frame: Up to 2 days
Incidence of adverse events (AE)
Time frame: Up to 33 days
Incidence of serious adverse events (SAE)
Time frame: Up to 33 days
Incidence of Laboratory Test Result Abnormalities
Time frame: Up to 11 days
Clearance (CL) derived from plasma concentration
Time frame: Up to 2 days
Terminal elimination half-life (t1/2) derived from plasma concentration
Time frame: Up to 2 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 2 days
Terminal elimination phase rate constant (λz) derived from plasma concentration
Time frame: Up to 2 days
Volume of distribution during terminal phase (Vz) derived from plasma concentration
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Time frame: Up to 2 days
Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration
Time frame: Up to 2 days