drugset / Trial / NCT02536911

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

NCT02536911

Phase 1 Completed 24 enrolled Genzyme, a Sanofi Company
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-09
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Eliglustat Small molecule Oral

Indications