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Taste Evaluation of Different Liquid Formulations With Eliglustat

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02422654
Collaborator
(none)
8
Enrollment
1
Location
15
Arms
30
Duration (Days)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Concentration 1 eliglustat in vehicle A

Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

Drug: eliglustat
Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
Other Names:
  • GZ385660

    		•
    Experimental: Concentration 1 eliglustat in vehicle B

    Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 1 eliglustat in vehicle C

    Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 1 eliglustat in vehicle D

    Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 1 eliglustat in vehicle E

    Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 2 eliglustat in vehicle A

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 2 eliglustat in vehicle B

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 2 eliglustat in vehicle C

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 2 eliglustat in vehicle D

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 2 eliglustat in vehicle E

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 3 eliglustat in vehicle A

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 3 eliglustat in vehicle B

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 3 eliglustat in vehicle C

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 3 eliglustat in vehicle D

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•
    Experimental: Concentration 3 eliglustat in vehicle E

    Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion

    Drug: eliglustat
    Pharmaceutical form:liquid formulation Route of administration: oral without ingestion
    Other Names:
  • GZ385660

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [Each day for 3 days immediately post expectorating the sample]

    2. Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [Each day for 3 days 5 minutes post expectorating the sample]

    3. Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [Each day for 3 days 15 minutes post expectorating the sample]

    4. 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

    1. Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations [up to 3 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 840001 Evansville Indiana United States 47710

    Sponsors and Collaborators

    • Genzyme, a Sanofi Company

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genzyme, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT02422654
    Other Study ID Numbers:
    • ACC14373
    • U1111-1168-5133
    First Posted:
    Apr 21, 2015
    Last Update Posted:
    May 27, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Gaucher Disease
    Eliglustat

    Study Results

    No Results Posted as of May 27, 2015