Taste Evaluation of Different Liquid Formulations With Eliglustat

Genzyme, a Sanofi Company8 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gaucher Disease

Interventions

eliglustatDRUG

Pharmaceutical form:liquid formulation Route of administration: oral without ingestion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria : * Healthy male and female subjects, 18 to 55 years of age, inclusive. * Normal smell and taste ability to discriminate odor and flavor differences. Exclusion criteria: * Poor metabolizer phenotype status for CYP2D6 (predicted based on genotype). * Subject who has smoked within 3 months of inclusion. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Investigational Site Number 840001

Evansville, Indiana, United States

Outcomes

Primary Outcomes

Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability

Time frame: Each day for 3 days immediately post expectorating the sample

Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability

Time frame: Each day for 3 days 5 minutes post expectorating the sample

Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability

Time frame: Each day for 3 days 15 minutes post expectorating the sample

Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability

Time frame: Each day for 3 days 30 minutes post expectorating the sample

Secondary Outcomes

Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations

Time frame: up to 3 days

Data from ClinicalTrials.gov

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