NCT02422654

Taste Evaluation of Different Liquid Formulations With Eliglustat

A Single-blind, Randomized, Unbalanced Crossover Design With 5 Vehicles, 5 Periods, and 5 Sequences, Repeated-doses (With no Ingestion) Study to Assess the Palatability of Eliglustat Prototype Liquid Formulations in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: The purpose of this study is to assess the palatability of eliglustat prototype liquid formulations in healthy subjects.

Detailed description

The total duration of the study for each subject will be approximately 5 weeks (screening period from Day -28 to Day -2, treatment period of 3 days, and follow-up call on Day 5).

Conditions

• Gaucher Disease

Interventions

Type	Name	Description
DRUG	eliglustat	Pharmaceutical form:liquid formulation Route of administration: oral without ingestion

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-04-21
• Last updated: 2015-05-27

Locations

1 site across 1 country: United States