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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1294-8432 | Registry Identifier | ICTRP |
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The primary objective of the study is to evaluate dose proportionality and pharmacokinetics for three different dose levels of eliglustat after single and repeated administration.
Duration of the study for each subject will be between 42 to 79 days, including a screening period up to 28 days, 3 treatment periods of 7 days each period, a washup period of 7-10 days, and an end-of-study visit 8+/-2 days after the last administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | CYP2D6 Extensive metabolizers - dose 1, 2 and 3 of eliglustat |
|
| Group 2 | Experimental | CYP2D6 Poor metabolizers - dose 1, 2 and 3 of eliglustat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eliglustat | Drug | Pharmaceutical form:Capsule-Route of administration:Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) parameter: Cmax | Eliglustat after single and repeated doses: Maximum plasma concentration observed (Cmax) | Multiple timepoints up to Day 35 |
| Pharmacokinetic (PK) parameter: tmax | Eliglustat after single and repeated doses: Time to reach Cmax | Multiple timepoints up to Day 35 |
| Pharmacokinetic (PK) parameter: AUC0-T | Eliglustat after single and repeated doses: Area under the plasma concentration versus time curve calculated using the trapezoidal method (AUC0-T) | Multiple timepoints up to Day 35 |
| Pharmacokinetic (PK) parameter: AUC | Eliglustat after single and repeated doses: Area under the plasma concentration versus time curve (AUC) | Multiple timepoints up to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) parameter: AUClast | Eliglustat after single and repeated doses: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast | Multiple timepoints up to Day 35 |
| Pharmacokinetic (PK) parameter: tlast |
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Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The following classes of drugs administered within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy:
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 |
|---|---|---|---|---|---|---|
| M.D.Covance Clinical Research Unit 1341 W | Dallas | Texas | 75247 | 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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Eliglustat after single and repeated doses: Time corresponding to the last concentration above the limit of quantification, Clast |
| Multiple timepoints up to Day 35 |
| Pharmacokinetic (PK) parameter: CL/F | Eliglustat after single and repeated doses: Eliglustat after repeated dose: CL/F | Multiple timepoints up to Day 35 |
| Pharmacokinetic (PK) parameter: t1/2z | Eliglustat after single and repeated doses: Terminal half-life associated with the terminal slope (λz) | Multiple timepoints up to Day 35 |
| Pharmacokinetic (PK) parameter: Ctrough | Eliglustat after single and repeated doses: Plasma concentration observed just before treatment administration during repeated dosing | Multiple timepoints up to Day 35 |
| Number of participants with treatment emergent adverse events, serious adverse events, and adverse event of special interest | Safety was assessed using clinical laboratory evaluations, ECG parameters, and adverse events spontaneously reported by the subject or observed by the Investigator | Up to Day 42 |
| 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 |