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Completed

NCT Number: NCT01764776

Effect of Hepatic Impairment on LDE225..

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.

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Key information

Conditions

Normal Hepatic Function Impaired Hepatic Function

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

LDE225

Drug

LDE225

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 outcomes

  1. Occurrence of abnormal safety laboratory parameters

    Time frame: 8 weeks

    Laboratory assessments

  2. Plasma protein binding of LDE225

    Time frame: 1 day

    Plasma protein binding of LDE225

  3. Occurrence of changes in ECGs

    Time frame: 8 weeks

    ECGs

  4. Occurrence of adverse event

    Time frame: 8 weeks

    follow up on any adverse event

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 10, 2013
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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