Effect of Hepatic Impairment on LDE225..

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01764776

Enrollment

Registered

2013-01-10

Start date

2013-03-31

Completion date

2015-03-31

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Hepatic Function, Normal Hepatic Function

Keywords

LDE225, Pharmacokinetics, PK, Postmenopausal women, normal hepatic function, mild hepatic impairment, moderate hepatic impairment, severe hepatic impairment

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.

Interventions

DRUGLDE225

LDE225

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

Measure	Time frame	Description
Occurrence of changes in ECGs	8 weeks	ECGs
Occurrence of adverse event	8 weeks	follow up on any adverse event
Occurrence of abnormal safety laboratory parameters	8 weeks	Laboratory assessments
Plasma protein binding of LDE225	1 day	Plasma protein binding of LDE225

Countries

Belgium, Bulgaria, Germany, Israel, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026