Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Taste Evaluation of Different Liquid Formulations With Eliglustat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02422654
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:

Primary Objective:

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


Condition or disease Intervention/treatment Phase
Gaucher Disease Drug: eliglustat Phase 1

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gaucher Disease
Drug Information available for: Eliglustat

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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: 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
Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: GZ385660




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 Measures :
  1. Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations [ Time Frame: up to 3 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422654


Locations
Layout table for location information
United States, Indiana
Investigational Site Number 840001
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Layout table for additonal information
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02422654     History of Changes
Other Study ID Numbers: ACC14373
U1111-1168-5133 ( Other Identifier: UTN )
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Gaucher Disease
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Eliglustat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action