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Completed

NCT Number: NCT06143904

A Study to Evaluate Absolute Bioavailability, Absorption, Metabolism, and Excretion of Genz-112638 in Healthy Male Participants

Objectives:

To determine pharmacokinetic (PK) variables, including absolute bioavailability (F), of Genz-99067, the free base of the L-tartaric acid salt of Genz-112638 as it exists in plasma, after a single intravenous (IV) dose and after a single oral dose of Genz-112638 (unlabeled).

To determine the PK, total recovery, routes and rates of excretion, and the metabolic profile of Genz-99067 after 5 days of BID oral dosing with unlabeled Genz-112638 followed by a single dose of [14C]-Genz-112638.

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Key information

Conditions

Gaucher's Disease Type I 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–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

The maximum study duration for an individual subject was approximately 65 days from the beginning of Screening through the Safety Follow-up visit.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Having given written informed consent prior to undertaking any study-related procedure The subject has a body weight of 50 to 100 kg [110 to 220 pounds (lb)] with a body mass index (BMI) less than 30 kilograms per square meter (kg/m2) at Screening.

The subject's physical examination results, vital signs, laboratory assessments, and cardiac assessments are within normal limits or, if abnormal, are not clinically significant at Screening and Day -1. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

Prolonged QTc interval (eg, repeated demonstration of a QTc interval ≥450 msec), family history of long QT or Brugada Syndrome, and/or history of sudden death in a first-degree relative.

The subject receives an immunization within 30 days of providing informed consent.

The subject has a history of drug allergies (eg, significant rash, hives, etc in response to antibiotics).

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Treatment and study plan

Genz-112638

Drug

Pharmaceutical form:Solution-Route of administration:IV

Other names: GZ385660/ eliglustat, Cerdelga

[14C]-Genz-112638

Drug

Pharmaceutical form:Solution-Route of administration:Oral

Other names: GZ385660/ eliglustat

Primary outcomes

  1. Assessment of pharmacokinetic (PK) parameter: Cmax

    Time frame: Multiple timepoints up to Day 26

    Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints

  2. Assessment of pharmacokinetic (PK) parameter: Tmax

    Time frame: Multiple timepoints up to Day 26

    Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints

  3. Assessment of pharmacokinetic (PK) parameter: AUC0-∞

    Time frame: Multiple timepoints up to Day 26

    Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints

  4. Assessment of pharmacokinetic (PK) parameter: AUC0 -τ

    Time frame: Multiple timepoints up to Day 26

    Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints

  5. Assessment of pharmacokinetic (PK) parameter: AUC0-∞/D

    Time frame: Multiple timepoints up to Day 26

    Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints

  6. Assessment of pharmacokinetic (PK) parameter: AUC0-τ/D

    Time frame: Multiple timepoints up to Day 26

    Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints

  7. Assessment of pharmacokinetic (PK) parameter: F

    Time frame: Multiple timepoints up to Day 26

    Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints

  8. Assessment of pharmacokinetic (PK) parameter: CL/F

    Time frame: Multiple timepoints up to Day 26

    Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints

  9. Assessment of pharmacokinetic (PK) parameter: t½

    Time frame: Multiple timepoints up to Day 26

    Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints

  10. Pharmacokinetic (PK) parameter: Absolute bioavailability (F) of single-dose oral versus single-dose IV administration

    Time frame: Multiple timepoints up to Day 26

  11. Assessment of pharmacokinetic (PK) parameter: Total radioactivity excreted in urine and feces

    Time frame: Multiple timepoints up to Day 26

    Total radioactivity excreted in urine and feces will be converted to percentage of radioactive dose.

  12. Assessment of pharmacokinetic (PK) parameter: Total radioactivity in whole blood and plasma

    Time frame: Multiple timepoints up to Day 26

    Total radioactivity in whole blood and plasma will be converted to ngEq/g Genz-99067 concentration for whole blood and ngEq/mL for plasma, based on the dose specific activity.

  13. Assessment of pharmacokinetic (PK) parameter: % relative abundance of each component in samples of plasma or excreta

    Time frame: Multiple timepoints up to Day 26

    It will be estimated as [(radioactivity for the HPLC peak)/(total radioactivity injected per HPLC run) x 100].

  14. Assessment of pharmacokinetic (PK) parameter: The percentage of the administered dose attributed to each component in samples of urine or feces

    Time frame: Multiple timepoints up to Day 26

    It will be estimated as [(% relative abundance)/100 x (percentage of radioactive dose in the sample)].

  15. Assessment of pharmacokinetic (PK) parameter: The radioactivity of [14C]-Genz-99067 and each major metabolite in plasma, as identified by radio-profiling

    Time frame: Multiple timepoints up to Day 26

    It will be converted to equivalent concentrations as [(% relative abundance)/100 x (equivalent concentration of total radioactivity in the sample)].

  16. Noncompartmental PK parameters: AUC0-t

    Time frame: Multiple timepoints up to Day 26

  17. Noncompartmental PK parameters: AUC0-∞

    Time frame: Multiple timepoints up to Day 26

  18. Noncompartmental PK parameters: Cmax

    Time frame: Multiple timepoints up to Day 26

  19. Noncompartmental PK parameters: Tmax

    Time frame: Multiple timepoints up to Day 26

  20. Noncompartmental PK parameters: t½

    Time frame: Multiple timepoints up to Day 26

  21. Noncompartmental PK parameters: Vz/F

    Time frame: Multiple timepoints up to Day 26

  22. Noncompartmental PK parameters: CL/F

    Time frame: Multiple timepoints up to Day 26

  23. Noncompartmental PK parameters for urine and feces: Cum Ae

    Time frame: Multiple timepoints up to Day 26

  24. Noncompartmental PK parameters for urine and feces: % dose

    Time frame: Multiple timepoints up to Day 26

  25. Renal clearance (CLR) for total plasma radioactivity and Genz-99067

    Time frame: Multiple timepoints up to Day 26

  26. PK parameters [AUC0-τ, AUC0-∞, Cmax, Tmax, t½] and metabolite ratio for metabolite(s) of Genz-99067

    Time frame: Multiple timepoints up to Day 26

Secondary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs), serious adverse event (SAEs), and adverse event of special interest (AESI)

    Time frame: Up to Day 33

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

An Open-Label Study to Evaluate the Absolute Bioavailability of Genz-112638 and the Absorption, Metabolism, and Excretion of [14C]-Genz-112638 in Male Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 22, 2023
Registry last updated
Nov 22, 2023

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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