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

NCT ID: NCT06188325

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-03-26

Brief 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.

Detailed 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.

Conditions

Gaucher's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1

CYP2D6 Extensive metabolizers - dose 1, 2 and 3 of eliglustat

Group Type: EXPERIMENTAL

Eliglustat

Intervention Type: DRUG

Pharmaceutical form:Capsule-Route of administration:Oral

Group 2

CYP2D6 Poor metabolizers - dose 1, 2 and 3 of eliglustat

Group Type: EXPERIMENTAL

Eliglustat

Intervention Type: DRUG

Pharmaceutical form:Capsule-Route of administration:Oral

Interventions

Eliglustat

Pharmaceutical form:Capsule-Route of administration:Oral

Intervention Type: DRUG

Other Intervention Names

GZ385660; Cerdelga

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

M.D.Covance Clinical Research Unit 1341 W

Dallas, Texas, United States

Countries

United States

Other Identifiers

U1111-1294-8432

Identifier Type: REGISTRY

Identifier Source: secondary_id

PKM14281

Identifier Type: -

Identifier Source: org_study_id