Taste Evaluation of Different Liquid Formulations With Eliglustat
Status and phase
Completed
Phase 1
Conditions
Gaucher Disease
Treatments
Drug: eliglustat
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
Primary Objective:
The purpose of this study is to assess the palatability of eliglustat prototype liquid formulations in healthy subjects.
Full 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).
Enrollment
8 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Single Blind
8 participants in 15 patient groups
Concentration 1 eliglustat in vehicle A
Experimental group
Description:
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 1 eliglustat in vehicle B
Experimental group
Description:
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 1 eliglustat in vehicle C
Experimental group
Description:
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 1 eliglustat in vehicle D
Experimental group
Description:
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 1 eliglustat in vehicle E
Experimental group
Description:
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 2 eliglustat in vehicle A
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 2 eliglustat in vehicle B
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 2 eliglustat in vehicle C
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 2 eliglustat in vehicle D
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 2 eliglustat in vehicle E
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 3 eliglustat in vehicle A
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 3 eliglustat in vehicle B
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 3 eliglustat in vehicle C
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 3 eliglustat in vehicle D
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Concentration 3 eliglustat in vehicle E
Experimental group
Description:
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
Treatment:
Drug: eliglustat
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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