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Small Molecule

Venglustat for Liver Dysfunction

Phase 1

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 20

Awards & highlights

Study Summary

This trial studies the effects of hepatic impairment on venglustat exposure in male and female participants aged 18-79. They will receive a single dose and be monitored for 42 days.

Who is the study for?

Adults aged 18-79 with varying degrees of liver dysfunction (mild, moderate, severe) or normal liver function can join this study. They must weigh within certain limits and have a BMI of 18-40 kg/m2. Participants need to use double contraception methods and cannot be pregnant or donating sperm/ova. Those with stable chronic liver disease are eligible if they meet specific lab criteria.Check my eligibility

What is being tested?

The trial is testing the effects of a single dose of Venglustat on adults with different levels of hepatic impairment compared to those with normal liver function. It's an open-label study where participants will stay in the institution until Day 5 post-dosing and attend several follow-up visits over approximately six weeks.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects for Venglustat may include issues related to its impact on liver function since it's being tested specifically for pharmacokinetics in individuals with hepatic impairments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the plasma concentration versus time curve extrapolated to infinity (AUC)

Maximum venglustat plasma concentration observed (Cmax)

Secondary outcome measures

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

Time to maximum venglustat plasma concentration (tmax)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Participants with severe hepatic impairmentExperimental Treatment1 Intervention

Venglustat single dose on Day 1

Group II: Participants with normal hepatic functionExperimental Treatment1 Intervention

Venglustat single dose on Day 1

Group III: Participants with moderate hepatic impairmentExperimental Treatment1 Intervention

Venglustat single dose on Day 1

Group IV: Participants with mild hepatic impairmentExperimental Treatment1 Intervention

Venglustat single dose on Day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venglustat (GZ402671)

2023

Completed Phase 1

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,163 Previous Clinical Trials

3,512,454 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

857 Previous Clinical Trials

2,019,273 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research looking for individuals aged 45 and above to participate?

"This medical trial is open to participants who are 18 years of age or older and have not exceeded the maximum eligible age of 79."

Answered by AI

Does having mild hepatic impairment increase the risk for participants?

"Our team at Power assigned a safety rating of 1 to participants with mild hepatic impairment due to the limited clinical data backing up both efficacy and safety. This is because this trial falls under Phase 1."

Answered by AI

Are there currently vacancies in this research project?

"Per the information available on clinicaltrials.gov, recruiting for this medical trial is ongoing and was first began on January 18th 2023 with a most recent update occurring at the end of that month."

Answered by AI

How many individuals are involved in the current clinical trial?

"Affirmative. Clinicaltrials.gov has the record that this research study is actively seeking participants since its initiation on January 18th 2023 and most recently updated on January 30th 2023. 32 individuals are needed to be signed up from 3 distinct sites for successful completion of trial."

Answered by AI

Is it possible to partake in this clinical exploration?

"This clinical trial is searching for 32 individuals aged between 18 and 79, with liver dysfunction. In addition to this condition, the following criteria must also be met: body weight that falls in a specific range depending on gender; double contraception methods (for both male and female participants); non-pregnant or breastfeeding status for females; abstaining from donating ova/ovum by women; capability of providing an informed consent signature; mild, moderate or severe hepatic impairment as assessed by Child-Pugh classification system; laboratory parameters within acceptable range if there's hepatic impairment present (with serum creatinine at lower level than norm and"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function

2023. "A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05718258.