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Effect of Hepatic Impairment on LDE225..

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01764776
First received: January 8, 2013
Last updated: February 13, 2017
Last verified: February 2017
  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: No masking
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:

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01764776     History of Changes
Other Study ID Numbers: CLDE225A2113
Study First Received: January 8, 2013
Last Updated: February 13, 2017

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

ClinicalTrials.gov processed this record on May 25, 2017