Effect of Hepatic Impairment on LDE225..

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01764776
First received: January 8, 2013
Last updated: September 11, 2014
Last verified: September 2014
  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: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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.

Further study details as provided by Novartis:

Primary Outcome Measures:
  • LDE225A pharmacokinetic parameter Tmax [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Laboratory assessments

  • Plasma protein binding of LDE225 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Plasma protein binding of LDE225

  • Occurrence of changes in ECGs [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    ECGs

  • Occurrence of adverse event [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    follow up on any adverse event


Estimated Enrollment: 32
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Florida
University of Miami Div. of Clinical Pharmacology Recruiting
Miami, Florida, United States, 33136
Contact    305-243-5930      
Principal Investigator: Richard A. Preston         
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1200
Bulgaria
Novartis Investigative Site Recruiting
Sofia, Bulgaria, 1612
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 14050
Israel
Novartis Investigative Site Recruiting
Tel-Aviv, Israel, 64239
Russian Federation
Novartis Investigative Site Withdrawn
Troitsk, Russia, Russian Federation, 142190
Novartis Investigative Site Withdrawn
Moscow, Russian Federation, 117198
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01764776     History of Changes
Other Study ID Numbers: CLDE225A2113
Study First Received: January 8, 2013
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

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 October 22, 2014