CompletedPhase 1

Taste Evaluation of Different Liquid Formulations With Eliglustat

United States8 participantsStarted 2015-04

Plain-language summary

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

Who can participate

Age range18 Years – 55 Years

SexALL

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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.

What they're measuring

Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability

Timeframe: Each day for 3 days immediately post expectorating the sample

Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability

Timeframe: Each day for 3 days 5 minutes post expectorating the sample

Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability

Timeframe: Each day for 3 days 15 minutes post expectorating the sample

Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability

Timeframe: Each day for 3 days 30 minutes post expectorating the sample

Trial details

NCT IDNCT02422654

SponsorGenzyme, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05

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