Taste Evaluation of Different Liquid Formulations With Eliglustat

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

Detailed Description
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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).

Official Title
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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

Conditions
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Gaucher Disease

Intervention / Treatment
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* Drug: eliglustat


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concentration 1 eliglustat in vehicle A<br>Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 1 eliglustat in vehicle B<br>Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 1 eliglustat in vehicle C<br>Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 1 eliglustat in vehicle D<br>Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 1 eliglustat in vehicle E<br>Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 2 eliglustat in vehicle A<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 2 eliglustat in vehicle B<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 2 eliglustat in vehicle C<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 2 eliglustat in vehicle D<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 2 eliglustat in vehicle E<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 3 eliglustat in vehicle A<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 3 eliglustat in vehicle B<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 3 eliglustat in vehicle C<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 3 eliglustat in vehicle D<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|
| Experimental: Concentration 3 eliglustat in vehicle E<br>Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion | Drug: eliglustat<br>* Pharmaceutical form:liquid formulation Route of administration: oral without ingestion<br>* Other names: GZ385660;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability |  | Each day for 3 days 5 minutes post expectorating the sample | 
| Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability |  | Each day for 3 days 15 minutes post expectorating the sample | 
| Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability |  | Each day for 3 days 30 minutes post expectorating the sample | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations |  | up to 3 days |