The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
specified dose on specified days
Local Institution
Groningen, Netherlands
Maximum observed plasma concentration (Cmax)
Time frame: Up to 16 days
Time to attain maximum observed plasma concentration (tmax)
Time frame: Up to 16 days
Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)]
Time frame: Up to 16 days
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]
Time frame: Up to 16 days
Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
Time frame: Up to 16 days
Terminal elimination rate constant (kel)
Time frame: Up to 16 days
Terminal elimination half life, calculated as 0.693/kel (t1/2)
Time frame: Up to 16 days
Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
Time frame: Up to 16 days
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: Up to 16 days
Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
Time frame: Up to 16 days
Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
Time frame: Up to 16 days
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Cumulative amount of TRA excreted in urine (Aeurine)
Time frame: Up to 16 days
Cumulative amount of TRA excreted in feces (Aefeces)
Time frame: Up to 16 days
Cumulative amount of TRA excreted in bile (Aebile)
Time frame: Up to 16 days
Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
Time frame: Up to 16 days
Fraction of the dose administered excreted in urine (feurine)
Time frame: Up to 16 days
Fraction of the dose administered excreted in feces (fefeces)
Time frame: Up to 16 days
Fraction of the dose administered excreted in bile (febile)
Time frame: Up to 16 days
Fraction of the dose administered excreted in urine and feces (fetotal)
Time frame: Up to 16 days
Number of adverse events (AE)
Time frame: Up to 16 days
Number of serious adverse events (SAE)
Time frame: Up to 16 days
Number of laboratory test result abnormalities
Time frame: Up to 16 days
Heart rate measured by ECG
Time frame: Up to 16 days
PR-interval measured by ECG
Time frame: Up to 16 days
QRS-duration measured by ECG
Time frame: Up to 16 days
QT-interval measured by ECG
Time frame: Up to 16 days
QTc-interval (Fridericia's) measured by ECG
Time frame: Up to 16 days