Effect of Hepatic Impairment on LDE225..

A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDE225 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function.

This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.

Inclusion Criteria (all groups):

• Male and sterile or postmenopausal female age ≥18 to ≤70 years old.
• Normal Vital signs

Inclusion (group mild, moderate and severe hepatic impairment):

-Subjects with confirmed cirrhosis

Exclusion (all groups):

• Woman of childbearing potential and pregnant or lactating females or male not using condom
• Risk factors for torsades de pointes
• Clinically significant cardio-vascular disease
• severe or uncontrolled medical conditions
• Smokers consuming greater than 10 cigarettes or equivalent nicotine containing products per day.
• Use of investigational drugs (i.e. participation in any clinical investigation)

Exclusion for moderate, mild and severe groups:

• Symptoms or history of encephalopathy
• Clinical evidence of severe ascites

Exclusion Criteria:

-