Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects

NCT05238714 | Completed Phase 1 FDA Drug

• 3 other identifiers: BEX136732019-001041-41U1111-1180-5557
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• To determine the excretion balance and systemic exposure of radioactivity after oral administration of \[14C\]-venglustat.
• To determine the pharmacokinetics (PK) of venglustat and its contribution to the overall exposure of radioactivity.
• To determine the metabolic pathways, metabolite profile, chemical structures and main excretion route of the main venglustat metabolites and the metabolite contribution to the overall exposure of radioactivity. Secondary Objective: To assess the clinical and biological tolerability of oral solution of venglustat

Conditions

Disorders of Sphingolipid Metabolism; Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Percentage of radioactive dose excreted in urine and faeces

  Percentage of radioactive dose excreted in urine and faeces

  Day -1 up to max Day 43

• Cmax of plasma and blood radioactivity

  Maximum plasma or blood concentration observed

  Day 1 up to max Day 43

• AUC Last of plasma and blood radioactivity

  Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time, tlast (time corresponding to the last concentration above the limit of quantification, Clast)

  Day 1 up to max Day 43

• AUC Last of plasma venglustat

  Day 1 up to max Day 43

• tmax of plasma and blood radioactivity

  Time to Cmax

  Day 1 up to max Day 43

• tmax of plasma venglustat

  Time to reach Cmax

  Day 1 up to max Day 43

Secondary Outcomes (4)

• Number of participants with adverse events (AEs)

  Day 1 up to max Day 43

• Percentage of venglustat metabolites in plasma

  Day 1 up to max Day 43

• Percentage of venglustat metabolites in urine

  Day 1 up to max Day 43

• Percentage of venglustat metabolites in faeces

  Day 1 up to max Day 43

Study Arms (1)

[14C] venglustat

EXPERIMENTAL

Single dose of \[14C\] venglustat Oral Solution under fasting conditions

Drug: venglustat

Interventions

venglustat DRUG

Powder for Oral solution

[14C] venglustat

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• 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, body Mass Index 18 to 32 kg/m2, inclusive
• Certified as healthy by a comprehensive clinical assessment
• Normal vital signs after 10 minutes resting in supine position
• Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms≤PR≤230 msec, QRS≤120 msec, QTc≤450 msec and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant
• Laboratory parameters within the normal range
• Having given written informed consent prior to undertaking any study-related procedure
• Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
• Not under any administrative or legal supervision
• Normal renal function as expressed by a creatinine clearance \>80 mL/min as calculated by the Cockroft and Gault formula
• Male subjects who agree to use condoms, whose female partner(s) are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method (unless they underwent surgical sterilization) until 90 days after the end of study

You may not qualify if:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
• Symptomatic postural hypotension, irrespective of the decrease in blood pressure.
• Presence or history of clinically significant drug hypersensitivity, or allergic disease diagnosed and treated by a physician that in the opinion of the Investigator would compromise subject safety.
• History or presence of drug or alcohol abuse (alcohol consumption more than 14 units per week on a regular basis) in the 5 years prior to screening.
• Smoking or using nicotine replacement products or e-cigarettes regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled).
• Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening.
• Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
• Any subject enrolled in or having participated, in \[this or\] any other clinical study involving an investigational medicinal product (IMP) according to applicable regulations/guidelines in the 3 months prior to dosing of this study.
• Any subject who cannot be contacted in case of emergency.
• Any subject who is the Investigator or any sub investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
• Confirmed positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, tricyclic antidepressants, opiates including methadone).
• Positive alcohol breath test

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

Investigational Site Number :8260001

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Location

Related Links

• BEX13673 Plain Language Results Summary

MeSH Terms

Interventions

venglustat

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: May 26, 2020
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)