An Open-label Two-stage Pharmacokinetic and Tolerability Study of Eliglustat Tartrate Given as a Single Dose in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function

NCT02536937 Phase 1 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 1
Status	COMPLETED
Enrolment	32
Start date	2015-09
Completion	2017-01

Conditions

• Gaucher Disease

Interventions

• eliglustat

Primary outcomes

• - Assessment of PK parameter: Maximum plasma concentration observed (Cmax) — 3 days
• - Assessment of PK parameter: Area under the plasma concentration (AUC) — 3 days

Countries

United States