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Completed

NCT Number: NCT06193304

A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth

A study to assess the absorption of eliglustat through the mouth in healthy subjects and the safety of any systemic exposure resulting from oral surface absorption of eliglustat in healthy subjects.

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Key information

Conditions

Gaucher's Disease Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gaucher Disease 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

Covance Clinical Researsh Unit

Evansville, Indiana, 47710, United States

About this study

Duration of the study for each subject, not including screening, will be 3 days including follow-up.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Body weight between 50.0 and 100.0 kg, inclusive, for males, and between 40.0 and 90.0 kg, inclusive, for females, body mass index between 18.0 and 30.0 kg/m2, inclusive.

Having given written informed consent prior to undertaking any study-related procedure.

Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, and ecg).

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.

Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Treatment and study plan

Eliglustat

Drug

Pharmaceutical form:solution -Route of administration: Oral wihtout ingestion

Other names: GZ385660, CERDELGA

Primary outcomes

  1. Plasma pharmacokinetic (PK) parameter: Cmax

    Time frame: Multiple timepoints on Day 1

    Maximum plasma concentration observed (Cmax)

  2. Plasma pharmacokinetic (PK) parameter tmax

    Time frame: Multiple timepoints on Day 1

    Time to reach Cmax (tmax)

  3. Plasma pharmacokinetic (PK) parameter AUClast

    Time frame: Multiple timepoints on Day 1

    Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast (AUClast)

  4. Plasma pharmacokinetic (PK) parameter AUC 0-2h

    Time frame: Multiple timepoints on Day 1

    Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to 2 hours (h) post dose (AUC0-2h)

  5. Plasma pharmacokinetic (PK) parameter AUC 2-4h

    Time frame: Multiple timepoints on Day 1

    Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 2 hours post dose to 4 hours post dose (AUC2-4h)

  6. Plasma pharmacokinetic (PK) parameter AUC 4-6h

    Time frame: Multiple timepoints on Day 1

    Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 4 hours post dose to 6 hours post dose (AUC4-6h)

  7. Plasma pharmacokinetic (PK) parameter tlast

    Time frame: Multiple timepoints on Day 1

Secondary outcomes

  1. Treatment emergent adverse events during the study

    Time frame: Up to Day 3

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

An Open-label Study to Assess the Absorption Through the Mouth After Three Repeated 50 mg Doses of Eliglustat Solution, Separated by 2-hour Intervals, Held in the Mouth for 30 Seconds With Swishing But Without Ingestion, in Healthy Subjects

Acronym: Acronym

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

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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