Taste Evaluation of Different Liquid Formulations With Eliglustat

Gaucher Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422654
• Other study ID #: ACC14373
• Secondary ID: U1111-1168-5133
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2015
• Last updated: May 26, 2015
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

The purpose of this study is to assess the palatability of eliglustat prototype liquid formulations in healthy subjects.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gaucher Disease

Intervention

Drug:
• eliglustat
Pharmaceutical form:liquid formulation Route of administration: oral without ingestion

Locations

Country	Name	City	State
United States	Investigational Site Number 840001	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability		Each day for 3 days immediately post expectorating the sample	No
Primary	Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability		Each day for 3 days 5 minutes post expectorating the sample	No
Primary	Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability		Each day for 3 days 15 minutes post expectorating the sample	No
Primary	Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability		Each day for 3 days 30 minutes post expectorating the sample	No
Secondary	Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations		up to 3 days	No