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Completed

NCT Number: NCT02422654

Taste Evaluation of Different Liquid Formulations With Eliglustat

Primary Objective:

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

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Key information

Conditions

Gaucher Disease Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Sphingolipidoses

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 840001

Evansville, Indiana, 47710, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eliglustat

Drug

Pharmaceutical form:liquid formulation

Route of administration: oral without ingestion

Other names: GZ385660

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations

    Time frame: up to 3 days

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2015
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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