Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatic Function Abnormal

Outcome Measures

Primary Outcomes (2)

Maximum venglustat plasma concentration observed (Cmax)
Baseline to Day 20
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Baseline to Day 20

Secondary Outcomes (2)

Time to maximum venglustat plasma concentration (tmax)
Baseline to Day 20
Number of participants with adverse event (AE), treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESI)
Baseline to Day 20

Study Arms (4)

Participants with mild hepatic impairment

EXPERIMENTAL

Venglustat single dose on Day 1

Drug: Venglustat (GZ402671)

Participants with normal hepatic function

EXPERIMENTAL

Venglustat single dose on Day 1

Drug: Venglustat (GZ402671)

Participants with moderate hepatic impairment

EXPERIMENTAL

Venglustat single dose on Day 1

Drug: Venglustat (GZ402671)

Interventions

Venglustat (GZ402671)Drug

Pharmaceutical form: tablet Route of administration: oral

Participants with mild hepatic impairmentParticipants with moderate hepatic impairmentParticipants with normal hepatic functionParticipants with severe hepatic impairment

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent.
Body weight between 50.0 and 115.0 kg, inclusive, if male; between 40.0 and 100 kg, inclusive, if female, and body mass index (BMI) within the range 18 to 40 kg/m2, inclusive, at screening.

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (6)

Inland Empire Liver Foundation Site Number : 8400004

Rialto, California, 92377, United States

Clinical Pharmacology of Miami Site Number : 8400002

Miami, Florida, 33014, United States

Nucleus Network Site Number : 8400001

Saint Paul, Minnesota, 55114, United States

Volunteer Research Group-NOCCR Site Number : 8400003

Knoxville, Tennessee, 37920, United States

American Research Corporation Site Number : 8400005

San Antonio, Texas, 78215, United States

Investigational Site Number : 2760001

Kiel, 24105, Germany

MeSH Terms

Conditions

Liver Diseases

Interventions

venglustat

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

Clinical Sciences & Operations
Sanofi
STUDY DIRECTOR

Enrollment

26 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

January 18, 2023

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (4)

Participants with mild hepatic impairment

Participants with normal hepatic function

Participants with moderate hepatic impairment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Participants with severe hepatic impairment

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (4)

Participants with mild hepatic impairment

Participants with normal hepatic function

Participants with moderate hepatic impairment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Participants with severe hepatic impairment

You may not qualify if:

Data Sharing

Source record

Locations