- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02422654
Taste Evaluation of Different Liquid Formulations With Eliglustat
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
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Indiana
-
Evansville, Indiana, United States, 47710
- Investigational Site Number 840001
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lysosomal Storage Diseases
- Lipid Metabolism Disorders
- Brain Diseases, Metabolic
- Brain Diseases, Metabolic, Inborn
- Sphingolipidoses
- Lysosomal Storage Diseases, Nervous System
- Lipidoses
- Lipid Metabolism, Inborn Errors
- Gaucher Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Eliglustat
Other Study ID Numbers
- ACC14373
- U1111-1168-5133 (Other Identifier: UTN)
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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