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

NCT02536911 Phase 1 COMPLETED

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.

Details

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2015-09
Completion	2016-12

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