A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function
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.
Arms and Interventions
|Experimental: Group 1: Participants with Severe Hepatic Impairment|
Participants with severe hepatic impairment will receive single oral dose of apalutamide on Day 1 under fasted condition.
Apalutamide will be administered orally.
|Experimental: Group 2: Participants with Normal Hepatic Function|
Participants with normal hepatic function will receive single oral dose of apalutamide on Day 1 under fasted condition.
Apalutamide will be administered orally.
Primary Outcome Measures
- Area Under Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Apalutamide [Up to Day 57]
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.
- Area Under Concentration-time Curve from Time 0 to the Time of the Last Concentration (AUC[0-last]) of Apalutamide [Up to Day 57]
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.
- Peak Plasma Concentration (Cmax) of Apalutamide [Up to Day 57]
Cmax is defined as peak observed plasma concentration of the drug.
Secondary Outcome Measures
- Number of Participants with Adverse Event as a Measure of Safety and Tolerability [Up to 78 days]
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.
Participants must not have hepatic encephalopathy greater than or equal to (>=) Grade 3 (for participants with severe hepatic impairment) where the participant lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted
Participants with normal hepatic function must be in good health with no clinically significant findings from medical history, physical examination, vital signs, and laboratory evaluation, unless deemed not clinically significant by the investigator
Participants with normal hepatic function must have serum creatinine within normal limits and Creatinine Clearance (CrCL) greater than (>) 60 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) as calculated per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
Participants with severe hepatic impairment must have a total Child-Pugh score of 10 to 15 inclusive, as determined by the investigator during screening and on Day -1 prior to study drug administration. Source documents to substantiate the clinical diagnosis (for example, ultrasonography, liver biopsy, liver/spleen scan, laboratory results or clinical findings), and medical history will be reviewed and signed by the investigator
Participants with severe hepatic impairment must have CrCL) >= 45 mL/min/1.73 m^2 as calculated per CKD-EPI Creatinine Equation
Any participant with screening thyroid stimulating hormone (TSH) level > upper limit of normal (ULN)
Participants with normal hepatic function with presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function
Participants with normal hepatic function who have Hepatitis A immunoglobulin M positivity, Hepatitis B surface antigen (HBsAg) positivity, positive serology for Hepatitis B or Hepatitis C antibodies. Hepatitis B surface antibody positivity is not exclusionary if participant can provide evidence of Hepatitis B vaccination
Participants with severe hepatic impairment who have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the investigator or the sponsor's medical monitor
Participants with severe hepatic impairment previously diagnosed with hepatocellular carcinoma
Contacts and Locations
|1||Orlando Clinical Research Center||Orlando||Florida||United States||32809|
|2||VGR & NOCCR - Knoxville||Knoxville||Tennessee||United States||37920|
|3||FDI Clinical Research||San Juan||Puerto Rico||00927|
Sponsors and Collaborators
- Janssen Research & Development, LLC
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)None provided.