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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Gaucher's Disease

Treatments: Drug: Eliglustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT06188325

PKM14281

U1111-1294-8432 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Eliglustat

Group 2

Experimental group

Description:

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

Treatment:

Drug: Eliglustat