Effect of Hepatic Impairment on LDE225..

Novartis

Status and phase: Completed; Phase 1

Conditions: Impaired Hepatic Function; Normal Hepatic Function

Treatments: Drug: LDE225

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764776

CLDE225A2113

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

LDE225

Experimental group

Description:

LDE225

Treatment:

Drug: LDE225