Taste Evaluation of Different Liquid Formulations With Eliglustat
- Registration Number
- NCT02422654
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Concentration 2 eliglustat in vehicle B eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion Concentration 2 eliglustat in vehicle E eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion Concentration 1 eliglustat in vehicle A eliglustat Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion Concentration 1 eliglustat in vehicle B eliglustat Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion Concentration 1 eliglustat in vehicle C eliglustat Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion Concentration 1 eliglustat in vehicle D eliglustat Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion Concentration 1 eliglustat in vehicle E eliglustat Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion Concentration 2 eliglustat in vehicle A eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion Concentration 2 eliglustat in vehicle C eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion Concentration 2 eliglustat in vehicle D eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion Concentration 3 eliglustat in vehicle A eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion Concentration 3 eliglustat in vehicle D eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion Concentration 3 eliglustat in vehicle C eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion Concentration 3 eliglustat in vehicle B eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion Concentration 3 eliglustat in vehicle E eliglustat Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
- Primary Outcome Measures
Name Time Method Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability Each day for 3 days 30 minutes post expectorating the sample
- Secondary Outcome Measures
Name Time Method Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations up to 3 days
Trial Locations
- Locations (1)
Investigational Site Number 840001
🇺🇸Evansville, Indiana, United States
Investigational Site Number 840001🇺🇸Evansville, Indiana, United States