A Study to Evaluate Pharmacokinetic Parameters of Eliglustat in Healthy Volunteers Who Are CYP2D6 Extensive or Poor Metabolizers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06188325
• Other study ID #: PKM14281
• Secondary ID: U1111-1294-8432
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2018
• Est. completion date: March 26, 2018

Study information

• Verified date: December 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Gaucher Disease
• Gaucher's Disease

Intervention

Drug:
• Eliglustat
Pharmaceutical form:Capsule-Route of administration:Oral

Locations

Country	Name	City	State
United States	M.D.Covance Clinical Research Unit 1341 W	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

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