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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1168-5133 | Other Identifier | UTN |
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Primary Objective:
The purpose of this study is to assess the palatability of eliglustat prototype liquid formulations in healthy subjects.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concentration 1 eliglustat in vehicle A | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eliglustat | Drug | Pharmaceutical form:liquid formulation Route of administration: oral without ingestion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability | Each day for 3 days immediately post expectorating the sample | |
| Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability | Each day for 3 days 5 minutes post expectorating the sample | |
| Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability | Each day for 3 days 15 minutes post expectorating the sample | |
| Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability | Each day for 3 days 30 minutes post expectorating the sample |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations | up to 3 days |
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Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840001 | Evansville | Indiana | 47710 | United States |
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| ID | Term |
|---|---|
| D005776 | Gaucher Disease |
| ID | Term |
|---|---|
| D013106 | Sphingolipidoses |
| D020140 | Lysosomal Storage Diseases, Nervous System |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
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| ID | Term |
|---|---|
| C522917 | eliglustat |
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| Experimental |
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 B | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion |
|
|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008064 | Lipidoses |
| D008052 | Lipid Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |