Gaucher's Disease Clinical Trial
Official title:
A Randomized, Three-Period Crossover Study of Single and Repeated Doses for Three Different Strengths of Eliglustat in Healthy Adult, CYP2D6 Extensive and Poor Metabolizers
Verified date | December 2023 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | March 26, 2018 |
Est. primary completion date | March 26, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive. - Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, electrocardiograms (ECG)). - Having given written informed consent prior to undertaking any study-related procedure - Having given written informed consent prior to undertaking any study-related procedure 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. 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: - Drugs that are strong inducers of CYP3A (eg, rifampin, carbamazepine, phenobarbital,phenytoin, St. John's Wort). - Drugs that inhibit CYP2D6 or CYP3A (eg, paroxetine, ketoconazole, fluconazole,ranitidine). - Drugs that are substrates for P-gp (phenytoin, colchicine and dabigatran etexilate) or CYP2D6 (metoprolol, tricyclic antidepressants such as nortriptyline, amitriptyline, or imipramine, and phenothiazines such as perphenazine and chloropromazine). The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial. |
Country | Name | City | State |
---|---|---|---|
United States | M.D.Covance Clinical Research Unit 1341 W | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic (PK) parameter: Cmax | Eliglustat after single and repeated doses: Maximum plasma concentration observed (Cmax) | Multiple timepoints up to Day 35 | |
Primary | Pharmacokinetic (PK) parameter: tmax | Eliglustat after single and repeated doses: Time to reach Cmax | Multiple timepoints up to Day 35 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Pharmacokinetic (PK) parameter: tlast | Eliglustat after single and repeated doses: Time corresponding to the last concentration above the limit of quantification, Clast | Multiple timepoints up to Day 35 | |
Secondary | Pharmacokinetic (PK) parameter: CL/F | Eliglustat after single and repeated doses: Eliglustat after repeated dose: CL/F | Multiple timepoints up to Day 35 | |
Secondary | Pharmacokinetic (PK) parameter: t1/2z | Eliglustat after single and repeated doses: Terminal half-life associated with the terminal slope (?z) | Multiple timepoints up to Day 35 | |
Secondary | 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 | |
Secondary | 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 |
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