NCT02536911

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Gaucher Disease

Interventions

Type	Name	Description
DRUG	eliglustat	Pharmaceutical form: capsule Route of administration: oral

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-09-01
• Last updated: 2017-02-10

Locations

2 sites across 1 country: United States