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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1294-8055 | Registry Identifier | ICTRP |
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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.
Duration of the study for each subject, not including screening, will be 3 days including follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eliglustat | Experimental | Three repeated doses of eliglustat solution, separated by 2-hour intervals, held in the mouth for 30 seconds with swishing but without ingestion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eliglustat | Drug | Pharmaceutical form:solution -Route of administration: Oral wihtout ingestion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic (PK) parameter: Cmax | Maximum plasma concentration observed (Cmax) | Multiple timepoints on Day 1 |
| Plasma pharmacokinetic (PK) parameter tmax | Time to reach Cmax (tmax) | Multiple timepoints on Day 1 |
| Plasma pharmacokinetic (PK) parameter AUClast | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast (AUClast) | Multiple timepoints on Day 1 |
| Plasma pharmacokinetic (PK) parameter AUC 0-2h | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to 2 hours (h) post dose (AUC0-2h) | Multiple timepoints on Day 1 |
| Plasma pharmacokinetic (PK) parameter AUC 2-4h | 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) | Multiple timepoints on Day 1 |
| Plasma pharmacokinetic (PK) parameter AUC 4-6h | 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) | Multiple timepoints on Day 1 |
| Plasma pharmacokinetic (PK) parameter tlast | Multiple timepoints on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse events during the study | Up to Day 3 |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Researsh Unit | Evansville | Indiana | 47710 | United States |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D005776 | Gaucher Disease |
| ID | Term |
|---|---|
| D013106 | Sphingolipidoses |
| D020140 | Lysosomal Storage Diseases, Nervous System |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
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| ID | Term |
|---|---|
| C522917 | eliglustat |
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008064 | Lipidoses |
| D008052 | Lipid Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |