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

NCT06188325 | Completed Phase 1 FDA Drug

• 2 other identifiers: PKM14281U1111-1294-8432
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Gaucher's Disease

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic (PK) parameter: Cmax

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

  Multiple timepoints up to Day 35

• Pharmacokinetic (PK) parameter: tmax

  Eliglustat after single and repeated doses: Time to reach Cmax

  Multiple timepoints up to Day 35

• 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

• 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 Outcomes (6)

• Pharmacokinetic (PK) parameter: AUClast

  Multiple timepoints up to Day 35

• Pharmacokinetic (PK) parameter: tlast

  Multiple timepoints up to Day 35

• Pharmacokinetic (PK) parameter: CL/F

  Multiple timepoints up to Day 35

• Pharmacokinetic (PK) parameter: t1/2z

  Multiple timepoints up to Day 35

• Pharmacokinetic (PK) parameter: Ctrough

  Multiple timepoints up to Day 35

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Eliglustat

Group 2

EXPERIMENTAL

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

Drug: Eliglustat

Interventions

Eliglustat DRUG

Pharmaceutical form:Capsule-Route of administration:Oral

Also known as: GZ385660, Cerdelga

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

M.D.Covance Clinical Research Unit 1341 W

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Gaucher Disease

Interventions

eliglustat

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: January 1, 2018
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)