A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
Status:
Completed
Trial end date:
2012-06-14
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after
administration of a single 5 mg oral dose of preladenant in participants with hepatic
impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with
participants with mild hepatic impairment. Part 2 compares healthy volunteers with
participants with moderate hepatic impairment. Healthy volunteers in each part of this study
are to be matched with participants with hepatic impairment by race, age, gender, and body
mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI,
the area under the concentration-time curve from time 0 extrapolated to time of the last
quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched
healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within
the interval [0.50, 2.00].