The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of apalutamide in participants with severe hepatic impairment relative to participants with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Apalutamide will be administered orally.
Homestead Associates in Research Inc
Homestead, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
VGR & NOCCR - Knoxville
Knoxville, Tennessee, United States
Area Under Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Apalutamide
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C (last)/ lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Up to Day 57
Area Under Concentration-time Curve from Time 0 to the Time of the Last Concentration (AUC[0-last]) of Apalutamide
AUC(0-last) is defined as the time 0 to the time of the last measurable (non-below quantification limit) concentration of apalutamide calculated by linear-linear trapezoidal summation.
Time frame: Up to Day 57
Peak Plasma Concentration (Cmax) of Apalutamide
Cmax is defined as peak observed plasma concentration of the drug.
Time frame: Up to Day 57
Number of Participants with Adverse Event as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 78 days
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