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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Ariad Pharmaceuticals
• Treatments: Sirolimus

Criteria

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