Ridaforolimus in Patients With Hepatic Insufficiency (8669-046)

• Cmax of ridaforolimus [ Time Frame: through 288 hours post dose ] [ Designated as safety issue: No ]
• Tolerability of ridaforolimus measured by number of clinical and laboratory adverse experiences [ Time Frame: up to 14 days after last dose ] [ Designated as safety issue: Yes ]

This study will evaluate the pharmacokinetics of ridaforolimus (AUC(0-infinity) and Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.

• Sarcoma
• Hepatic Insufficiency

• Experimental: Hepatic Patients
  10 mg ridaforolimus
  Intervention: Drug: ridaforolimus
• Experimental: Healthy Subjects
  10 mg ridaforolimus
  Intervention: Drug: ridaforolimus

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:

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