Effect of Hepatic Impairment on LDE225..

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Normal Hepatic Function, Impaired Hepatic Function

Intervention / Treatment
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* Drug: LDE225


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LDE225<br>LDE225 | Drug: LDE225<br>* LDE225<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDE225A pharmacokinetic parameter Tmax | Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period | 8 weeks | 
| LDE225A pharmacokinetic parameter Cmax | Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period | 8 weeks | 
| LDE225A pharmacokinetic parameter AUClast | Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period | 8 weeks | 
| LDE225A pharmacokinetic parameter AUCinf | Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period | 8 weeks | 
| LDE225A pharmacokinetic parameter T1/2 | Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of abnormal safety laboratory parameters | Laboratory assessments | 8 weeks | 
| Plasma protein binding of LDE225 | Plasma protein binding of LDE225 | 1 day | 
| Occurrence of changes in ECGs | ECGs | 8 weeks | 
| Occurrence of adverse event | follow up on any adverse event | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LDE225, Pharmacokinetics, PK, Postmenopausal women, normal hepatic function, mild hepatic impairment, moderate hepatic impairment, severe hepatic impairment