The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Dose A single dose
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Cmax
The maximum (peak) observed drug concentration after single dose administration (mass x volume-1)
Time frame: Up to 8 days
Tmax
Time to reach the maximum (peak) plasma drug concentration after single dose administration (time)
Time frame: Up to 8 days
AUClast
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration sampling time (mass x time x volume-1)
Time frame: Up to 8 days
AUCinf
The area under the concentration-time curve from time zero to infinity (mass x time x volume-1)
Time frame: Up to 8 days
T1/2
The elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve
Time frame: Up to 8 days
CL/F
The apparent total body clearance of the drug from plasma (volume x time-1)
Time frame: Up to 8 days
Vz/F
The apparent volume of distribution during the terminal phase
Time frame: Up to 8 days
fu
Fraction of analyte unbound calculated in-vitro
Time frame: Day 1
Cmax,u
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The maximum (peak) observed plasma drug concentration after single dose administration (Cmax) of unbound drug (mass x time x volume-1), calculated as Cmax\*fu
Time frame: Day 1
AUClast,u
The area under the concentration-time curve from time zero to the last quantifiable concentration sampling time of unbound drug (mass x time x volume-1), calculated as AUClast\*fu
Time frame: Day 1
AUCinf,u
The area under the concentration-time curve from time zero to infinity of unbound drug (mass x time x volume-1), calculated as AUCinf\*fu
Time frame: Day 1
CL/F,u
The apparent total body clearance of drug from the plasma of unbound drug (volume x time-1), calculated as CL/F/fu
Time frame: Day 1