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Trial record 46 of 538 for:    Taste Disorders AND taste

Taste Evaluation of Different Liquid Formulations With Eliglustat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02422654
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE April 14, 2015
First Posted Date  ICMJE April 21, 2015
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE April 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2015)
  • Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [ Time Frame: Each day for 3 days immediately post expectorating the sample ]
  • Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [ Time Frame: Each day for 3 days 5 minutes post expectorating the sample ]
  • Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [ Time Frame: Each day for 3 days 15 minutes post expectorating the sample ]
  • Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [ Time Frame: Each day for 3 days 30 minutes post expectorating the sample ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [ Time Frame: up to 60 sec. post expectorating the sample ]
  • Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [ Time Frame: Each day for 3 days 5 minutes post expectorating the sample ]
  • Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [ Time Frame: Each day for 3 days 15 minutes post expectorating the sample ]
  • Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability [ Time Frame: Each day for 3 days 30 minutes post expectorating the sample ]
Change History Complete list of historical versions of study NCT02422654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations [ Time Frame: up to 3 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Taste Evaluation of Different Liquid Formulations With Eliglustat
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Gaucher Disease
Intervention  ICMJE Drug: eliglustat

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other Name: GZ385660
Study Arms  ICMJE
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
  • 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
    Intervention: Drug: eliglustat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02422654
Other Study ID Numbers  ICMJE ACC14373
U1111-1168-5133 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP