Taste Evaluation of Different Liquid Formulations With Eliglustat

May 26, 2015 updated by: Genzyme, a Sanofi Company

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

Primary Objective:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Evansville, Indiana, United States, 47710
        • Investigational Site Number 840001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660
Experimental: 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

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Names:
  • GZ385660

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Each day for 3 days 30 minutes post expectorating the sample

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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