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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02422654

Enrollment

Registered

2015-04-21

Start date

2015-04-30

Completion date

2015-05-31

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gaucher Disease

Brief 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).

Interventions

DRUGeliglustat

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability	Each day for 3 days immediately post expectorating the sample

Secondary

Measure	Time frame
Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations	up to 3 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026