Effect of Hepatic Impairment on LDE225..

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01764776

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Normal Hepatic Function Impaired Hepatic Function	Drug: LDE225	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

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.

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LDE225 LDE225	Drug: LDE225 LDE225

Arm

Intervention/Treatment

Experimental: LDE225

LDE225

Drug: LDE225

LDE225

Outcome Measures

Primary Outcome Measures

LDE225A pharmacokinetic parameter Tmax [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 [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 [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 [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 [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 [8 weeks]
Laboratory assessments
Plasma protein binding of LDE225 [1 day]
Plasma protein binding of LDE225
Occurrence of changes in ECGs [8 weeks]
ECGs
Occurrence of adverse event [8 weeks]
follow up on any adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Div. of Clinical Pharmacology	Miami	Florida	United States	33136
2	Novartis Investigative Site	Bruxelles		Belgium	1200
3	Novartis Investigative Site	Sofia		Bulgaria	1612
4	Novartis Investigative Site	Berlin		Germany	14050
5	Novartis Investigative Site	Tel-Aviv		Israel	64239