drugset / Trial / NCT02536937

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

NCT02536937

Phase 1 Completed 32 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: To study the effect of mild, moderate, and severe renal 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, moderate, and severe renal impairment in comparison with matched subjects with normal renal function.

Timeline

Start
2015-09
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Eliglustat Small molecule Oral

Indications