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Taste Evaluation of Different Liquid Formulations With Eliglustat

Primary Purpose

Gaucher Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
eliglustat
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gaucher Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Investigational Site Number 840001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Concentration 1 eliglustat in vehicle A

Concentration 1 eliglustat in vehicle B

Concentration 1 eliglustat in vehicle C

Concentration 1 eliglustat in vehicle D

Concentration 1 eliglustat in vehicle E

Concentration 2 eliglustat in vehicle A

Concentration 2 eliglustat in vehicle B

Concentration 2 eliglustat in vehicle C

Concentration 2 eliglustat in vehicle D

Concentration 2 eliglustat in vehicle E

Concentration 3 eliglustat in vehicle A

Concentration 3 eliglustat in vehicle B

Concentration 3 eliglustat in vehicle C

Concentration 3 eliglustat in vehicle D

Concentration 3 eliglustat in vehicle E

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2015
Last Updated
May 26, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT02422654
Brief Title
Taste Evaluation of Different Liquid Formulations With Eliglustat
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gaucher Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Concentration 1 eliglustat in vehicle A
Arm Type
Experimental
Arm Description
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 1 eliglustat in vehicle B
Arm Type
Experimental
Arm Description
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 1 eliglustat in vehicle C
Arm Type
Experimental
Arm Description
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 1 eliglustat in vehicle D
Arm Type
Experimental
Arm Description
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 1 eliglustat in vehicle E
Arm Type
Experimental
Arm Description
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 2 eliglustat in vehicle A
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 2 eliglustat in vehicle B
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 2 eliglustat in vehicle C
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 2 eliglustat in vehicle D
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 2 eliglustat in vehicle E
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 3 eliglustat in vehicle A
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 3 eliglustat in vehicle B
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 3 eliglustat in vehicle C
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 3 eliglustat in vehicle D
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Arm Title
Concentration 3 eliglustat in vehicle E
Arm Type
Experimental
Arm Description
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Intervention Type
Drug
Intervention Name(s)
eliglustat
Other Intervention Name(s)
GZ385660
Intervention Description
Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations
Time Frame
up to 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840001
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States

12. IPD Sharing Statement

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Taste Evaluation of Different Liquid Formulations With Eliglustat

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