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Taste Evaluation of Different Liquid Formulations With Eliglustat

NCT ID: NCT02422654

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-05-31

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.

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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).

Conditions

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Gaucher Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Concentration 1 eliglustat in vehicle A

Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 1 eliglustat in vehicle B

Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 1 eliglustat in vehicle C

Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 1 eliglustat in vehicle D

Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 1 eliglustat in vehicle E

Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 2 eliglustat in vehicle A

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 2 eliglustat in vehicle B

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 2 eliglustat in vehicle C

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 2 eliglustat in vehicle D

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 2 eliglustat in vehicle E

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 3 eliglustat in vehicle A

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 3 eliglustat in vehicle B

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 3 eliglustat in vehicle C

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 3 eliglustat in vehicle D

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Concentration 3 eliglustat in vehicle E

Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

Group Type EXPERIMENTAL

eliglustat

Intervention Type DRUG

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Interventions

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eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Intervention Type DRUG

Other Intervention Names

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GZ385660

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840001

Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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U1111-1168-5133

Identifier Type: OTHER

Identifier Source: secondary_id

ACC14373

Identifier Type: -

Identifier Source: org_study_id

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