Effect of Hepatic Impairment on LDE225..

Novartis Pharmaceuticals33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Normal Hepatic Function Impaired Hepatic Function

Interventions

LDE225DRUG

LDE225

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (5)

University of Miami Div. of Clinical Pharmacology

Miami, Florida, United States

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Berlin, Germany