NCT02422654

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1 month

First QC Date

April 14, 2015

Last Update Submit

May 26, 2015

Conditions

Gaucher Disease

Outcome Measures

Primary Outcomes (4)

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

    Each day for 3 days immediately post expectorating the sample

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

    Each day for 3 days 5 minutes post expectorating the sample

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

    Each day for 3 days 15 minutes post expectorating the sample

  • 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 Outcomes (1)

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

    up to 3 days

Study Arms (15)

Concentration 1 eliglustat in vehicle A

EXPERIMENTAL

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

Drug: eliglustat

Concentration 1 eliglustat in vehicle B

EXPERIMENTAL

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

Drug: eliglustat

Concentration 1 eliglustat in vehicle C

EXPERIMENTAL

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

Drug: eliglustat

Concentration 1 eliglustat in vehicle D

EXPERIMENTAL

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

Drug: eliglustat

Concentration 1 eliglustat in vehicle E

EXPERIMENTAL

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

Drug: eliglustat

Concentration 2 eliglustat in vehicle A

EXPERIMENTAL

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

Drug: eliglustat

Concentration 2 eliglustat in vehicle B

EXPERIMENTAL

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

Drug: eliglustat

Concentration 2 eliglustat in vehicle C

EXPERIMENTAL

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

Drug: eliglustat

Concentration 2 eliglustat in vehicle D

EXPERIMENTAL

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

Drug: eliglustat

Concentration 2 eliglustat in vehicle E

EXPERIMENTAL

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

Drug: eliglustat

Concentration 3 eliglustat in vehicle A

EXPERIMENTAL

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

Drug: eliglustat

Concentration 3 eliglustat in vehicle B

EXPERIMENTAL

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

Drug: eliglustat

Concentration 3 eliglustat in vehicle C

EXPERIMENTAL

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

Drug: eliglustat

Concentration 3 eliglustat in vehicle D

EXPERIMENTAL

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

Drug: eliglustat

Concentration 3 eliglustat in vehicle E

EXPERIMENTAL

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

Drug: eliglustat

Interventions

eliglustatDRUG

Pharmaceutical form:liquid formulation Route of administration: oral without ingestion

Also known as: GZ385660
Concentration 1 eliglustat in vehicle AConcentration 1 eliglustat in vehicle BConcentration 1 eliglustat in vehicle CConcentration 1 eliglustat in vehicle DConcentration 1 eliglustat in vehicle EConcentration 2 eliglustat in vehicle AConcentration 2 eliglustat in vehicle BConcentration 2 eliglustat in vehicle CConcentration 2 eliglustat in vehicle DConcentration 2 eliglustat in vehicle EConcentration 3 eliglustat in vehicle AConcentration 3 eliglustat in vehicle BConcentration 3 eliglustat in vehicle CConcentration 3 eliglustat in vehicle DConcentration 3 eliglustat in vehicle E

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects, 18 to 55 years of age, inclusive.
  • Normal smell and taste ability to discriminate odor and flavor differences.

You may not qualify if:

  • Poor metabolizer phenotype status for CYP2D6 (predicted based on genotype).
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site Number 840001

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Conditions

Gaucher Disease

Interventions

eliglustat

Condition Hierarchy (Ancestors)

SphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 21, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)