Effect of Hepatic Impairment on LDE225..

Impaired Hepatic Function Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764776
• Other study ID #: CLDE225A2113
• Status: Completed
• Phase: Phase 1
• Start date: March 2013
• Est. completion date: March 2015

Study information

• Verified date: June 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Impaired Hepatic Function
• Normal Hepatic Function

Intervention

Drug:
• LDE225
LDE225

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Bruxelles
Bulgaria	Novartis Investigative Site	Sofia
Germany	Novartis Investigative Site	Berlin
Israel	Novartis Investigative Site	Tel-Aviv
United States	University of Miami Div. of Clinical Pharmacology	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDE225A pharmacokinetic parameter Tmax	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	8 weeks
Primary	LDE225A pharmacokinetic parameter Cmax	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	8 weeks
Primary	LDE225A pharmacokinetic parameter AUClast	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	8 weeks
Primary	LDE225A pharmacokinetic parameter AUCinf	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	8 weeks
Primary	LDE225A pharmacokinetic parameter T1/2	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	8 weeks
Secondary	Occurrence of abnormal safety laboratory parameters	Laboratory assessments	8 weeks
Secondary	Plasma protein binding of LDE225	Plasma protein binding of LDE225	1 day
Secondary	Occurrence of changes in ECGs	ECGs	8 weeks
Secondary	Occurrence of adverse event	follow up on any adverse event	8 weeks

External Links

•   Results for CLDE225A2113 from Novartis Clinical Trials website