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Completed

NCT Number: NCT06188325

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

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.

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Key information

Conditions

Gaucher's Disease Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gaucher Disease Genetic Diseases, Inborn Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Sphingolipidoses

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

M.D.Covance Clinical Research Unit 1341 W

Dallas, Texas, 75247, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eliglustat

Drug

Pharmaceutical form:Capsule-Route of administration:Oral

Other names: GZ385660, Cerdelga

Primary outcomes

  1. Pharmacokinetic (PK) parameter: Cmax

    Time frame: Multiple timepoints up to Day 35

    Eliglustat after single and repeated doses: Maximum plasma concentration observed (Cmax)

  2. Pharmacokinetic (PK) parameter: tmax

    Time frame: Multiple timepoints up to Day 35

    Eliglustat after single and repeated doses: Time to reach Cmax

  3. Pharmacokinetic (PK) parameter: AUC0-T

    Time frame: Multiple timepoints up to Day 35

    Eliglustat after single and repeated doses: Area under the plasma concentration versus time curve calculated using the trapezoidal method (AUC0-T)

  4. Pharmacokinetic (PK) parameter: AUC

    Time frame: Multiple timepoints up to Day 35

    Eliglustat after single and repeated doses: Area under the plasma concentration versus time curve (AUC)

Secondary outcomes

  1. Pharmacokinetic (PK) parameter: AUClast

    Time frame: Multiple timepoints up to Day 35

    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

  2. Pharmacokinetic (PK) parameter: tlast

    Time frame: Multiple timepoints up to Day 35

    Eliglustat after single and repeated doses: Time corresponding to the last concentration above the limit of quantification, Clast

  3. Pharmacokinetic (PK) parameter: CL/F

    Time frame: Multiple timepoints up to Day 35

    Eliglustat after single and repeated doses: Eliglustat after repeated dose: CL/F

  4. Pharmacokinetic (PK) parameter: t1/2z

    Time frame: Multiple timepoints up to Day 35

    Eliglustat after single and repeated doses: Terminal half-life associated with the terminal slope (λz)

  5. Pharmacokinetic (PK) parameter: Ctrough

    Time frame: Multiple timepoints up to Day 35

    Eliglustat after single and repeated doses: Plasma concentration observed just before treatment administration during repeated dosing

  6. Number of participants with treatment emergent adverse events, serious adverse events, and adverse event of special interest

    Time frame: Up to Day 42

    Safety was assessed using clinical laboratory evaluations, ECG parameters, and adverse events spontaneously reported by the subject or observed by the Investigator

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 3, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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