Effect of Hepatic Impairment on LDE225..

Phase 1

Completed

• Conditions: Impaired Hepatic Function; Normal Hepatic Function
• Interventions: Drug: LDE225

• Registration Number: NCT01764776
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Study Start: 2013-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2017-06
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LDE225	LDE225	LDE225

Primary Outcome Measures

Name	Time	Method
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 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 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 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 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

Name	Time	Method
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
Occurrence of changes in ECGs	8 weeks	ECGs

Trial Locations

Locations (2)

University of Miami Div. of Clinical Pharmacology; 🇺🇸 Miami, Florida, United States

Novartis Investigative Site; 🇮🇱 Tel-Aviv, Israel