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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.
Details
| Lead sponsor | Genzyme, a Sanofi Company |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 8 |
| Start date | 2015-04 |
| Completion | 2015-05 |
Conditions
- Gaucher Disease
Interventions
- eliglustat
Primary outcomes
- 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
Countries
United States