Ridaforolimus in Patients With Hepatic Insufficiency (MK-8669-046)

A Single Dose Study to Investigate the Pharmacokinetics of Ridaforolimus in Patients With Hepatic Insufficiency

This study will evaluate the pharmacokinetics of ridaforolimus including the area under the concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.

Inclusion Criteria:

Hepatic Patients:

• Female patient is of non-child bearing potential
• Apart from hepatic insufficiency with features of cirrhosis, patient is otherwise in good health
• Patient has a diagnosis of chronic stable hepatic insufficiency with features of cirrhosis

Healthy Subjects:

• Female subject is of non-childbearing potential
• Subject is in good health

Exclusion Criteria:

Hepatic Patients and Healthy Subjects:

• Works a night shift and is not able to avoid night shift work during the study
• Has a history of stroke, seizure or major neurological disease
• Has a history of cancer
• Is unable to refrain from or anticipates the use of any prescription or non-prescription drugs during the study
• Consumes excessive amounts of alcohol or caffeine
• Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks