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Effect of Hepatic Impairment on LDE225..

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764776
First Posted: January 10, 2013
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Normal Hepatic Function Impaired Hepatic Function Drug: LDE225 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • LDE225A pharmacokinetic parameter Tmax [ Time Frame: 8 weeks ]
    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

  • LDE225A pharmacokinetic parameter Cmax [ Time Frame: 8 weeks ]
    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

  • LDE225A pharmacokinetic parameter AUClast [ Time Frame: 8 weeks ]
    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

  • LDE225A pharmacokinetic parameter AUCinf [ Time Frame: 8 weeks ]
    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

  • LDE225A pharmacokinetic parameter T1/2 [ Time Frame: 8 weeks ]
    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


Secondary Outcome Measures:
  • Occurrence of abnormal safety laboratory parameters [ Time Frame: 8 weeks ]
    Laboratory assessments

  • Plasma protein binding of LDE225 [ Time Frame: 1 day ]
    Plasma protein binding of LDE225

  • Occurrence of changes in ECGs [ Time Frame: 8 weeks ]
    ECGs

  • Occurrence of adverse event [ Time Frame: 8 weeks ]
    follow up on any adverse event


Enrollment: 33
Study Start Date: March 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDE225
LDE225
Drug: LDE225
LDE225

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764776


Locations
United States, Florida
University of Miami Div. of Clinical Pharmacology
Miami, Florida, United States, 33136
Belgium
Novartis Investigative Site
Bruxelles, Belgium, 1200
Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, 1612
Germany
Novartis Investigative Site
Berlin, Germany, 14050
Israel
Novartis Investigative Site
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01764776     History of Changes
Other Study ID Numbers: CLDE225A2113
First Submitted: January 8, 2013
First Posted: January 10, 2013
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
LDE225
Pharmacokinetics
PK
Postmenopausal women
normal hepatic function
mild hepatic impairment
moderate hepatic impairment
severe hepatic impairment