Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group
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|ClinicalTrials.gov Identifier: NCT01901133|
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : September 15, 2014
This study will assess the influence of hepatic impairment on the pharmacokinetics, safety and tolerability of a single dose of MDV3100 in male subjects.
The study will consist of two treatment arms. Arm A will assess the influence of mild hepatic impairment, and Arm B will assess the influence of moderate hepatic impairment. Data obtained from subjects with hepatic impairment will be compared to data from Body Mass Index (BMI) and age-matched subjects with normal hepatic function.
|Condition or disease||Intervention/treatment||Phase|
|Pharmacokinetics of MDV3100 Healthy Subjects Kidney Diseases||Drug: MDV3100||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of MDV3100 in Male Subjects With Mild or Moderate Hepatic Impairment and Normal Hepatic Function|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
|Experimental: A: Mild hepatic impairment subjects + control||
|Experimental: B: Moderate hepatic impairment subjects + control||
- Assessment of pharmacokinetics measured by AUC0-inf following single dose of MDV3100 [ Time Frame: Day 1 through Day 50 (25 times) ]Area under the plasma concentration - time curve extrapolated to infinity (AUC0-inf) in subjects with mild and moderate hepatic impairment to matched control subjects with normal hepatic function.
- Assessment of pharmacokinetics measured by Cmax following single dose of MDV3100 [ Time Frame: Day 1 through Day 50 (25 times) ]Maximum concentration (observed) (Cmax) in subjects with mild and moderate hepatic impairment to matched control subjects with normal hepatic function.
- Composite of pharmacokinetics following single dose of MDV3100 [ Time Frame: Day 1 through Day 50 (25 times) ]Measured by Time to attain Cmax (tmax), AUC up to last quantifiable concentration (AUC0-last), Apparent terminal elimination half life (t1/2), Apparent volume of distribution during the terminal phase after extra vascular dosing (Vz/F), Apparent total body clearance after extra vascular dosing (CL/F), Cmax, t1/2, AUC0-inf, Unbound maximum concentration (observed) (Cmax,u), Unbound AUC extrapolated to infinity (AUC0-inf,u), Unbound apparent total body clearance after extra vascular dosing (CLu/F), Unbound apparent volume of distribution during the terminal phase after extra vascular dosing (Vz,u/F), Fraction unbound (fu).
- Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG) and clinical safety laboratory and adverse events [ Time Frame: Day 1 through Day 50 ]For hepatic impaired subjects, additional Child-Pugh classification will be performed after MDV3100 administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901133
|Moldova, Republic of|
|Chisinau, Moldova, Republic of|
|Study Chair:||Operation Senior Research Manager||Astellas Pharma Europe B.V.|