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

Phase 1

Completed

• Conditions: Gaucher's Disease
• Interventions: Drug: Eliglustat

• Registration Number: NCT06193304
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2014-08-25
• Primary Completion: 2014-09-21
• Study Completion: 2014-09-21
• Status Verified: 2023-12
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Eliglustat	Eliglustat	Three repeated doses of eliglustat solution, separated by 2-hour intervals, held in the mouth for 30 seconds with swishing but without ingestion

Primary Outcome Measures

Name	Time	Method
Plasma pharmacokinetic (PK) parameter AUClast	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)
Plasma pharmacokinetic (PK) parameter AUC 0-2h	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)
Plasma pharmacokinetic (PK) parameter AUC 2-4h	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)
Plasma pharmacokinetic (PK) parameter AUC 4-6h	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)
Plasma pharmacokinetic (PK) parameter: Cmax	Multiple timepoints on Day 1	Maximum plasma concentration observed (Cmax)
Plasma pharmacokinetic (PK) parameter tmax	Multiple timepoints on Day 1	Time to reach Cmax (tmax)
Plasma pharmacokinetic (PK) parameter tlast	Multiple timepoints on Day 1

Secondary Outcome Measures

Name	Time	Method
Treatment emergent adverse events during the study	Up to Day 3

Trial Locations

Locations (1)

Covance Clinical Researsh Unit; 🇺🇸 Evansville, Indiana, United States