Effect of Hepatic Impairment on LDE225..

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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)

33 participants in 1 patient group

LDE225
Experimental group
Description:
LDE225
Treatment:
Drug: LDE225

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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