NCT01764776

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Normal Hepatic Function
• Impaired Hepatic Function

Interventions

Type	Name	Description
DRUG	LDE225	LDE225

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-01-10
• Last updated: 2020-12-19

Locations

5 sites across 5 countries: United States, Belgium, Bulgaria, Germany, Israel