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A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate

Gaucher Disease Clinical Trial

Official title:
An Open-label Pharmacokinetic and Tolerability Study of Eliglustat Tartrate Given as a Single Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function

Clinical Trial Summary

Primary Objective:

To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of eliglustat.

Secondary Objective:

To assess the tolerability of eliglustat tartrate given as a single dose in subjects with mild and moderate hepatic impairment in comparison with matched subjects with normal hepatic function.

Clinical Trial Description

The total study duration from screening period is approximately 31 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02536911
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date September 2015
Completion date December 2016
View Details
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