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Venglustat GZ/SAR402671

Phase 1

Healthy Volunteers | Small molecule | Nephrology |Sanofi|Last Updated: Apr 25, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

BREAKTHROUGH_THERAPYFAST_TRACKORPHAN_DRUGPRIORITY_REVIEW

Clinical trial landscape

Venglustat GZ/SAR402671 · 1 trial · 2 indications

Phase 1 1
NCT03687554Effect of Venglustat in Patients With Renal ImpairmentHealthy Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
Effect of Venglustat in Patients With Renal Impairment
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Study Endpoints

Primary Endpoints

Assessment of pharmacokinetic (PK) parameters of Venglustat: Area under the curve (AUC)
Day 1 to Day 10

Venglustat area under the plasma concentration versus time curve (AUC)

Secondary Endpoints

Venglustat plasma pharmacokinetic (PK) parameter: Cmax
Day 1
Venglustat plasma pharmacokinetic (PK) parameter: AUClast
Day 1 to Day 10
Venglustat plasma pharmacokinetic (PK) parameter: unbound Cmax
Day 1 to Day 10
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VenglustatEXPERIMENTALSingle dose of Venglustat is given, orally under fasting conditions

Interventions

NameTypeDescription
Venglustat GZ/SAR402671DRUGPharmaceutical form: Hard Capsule Route of administration: Oral
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Eligibility Criteria

Age Range18 Years to 79 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: For all Subjects: * Male and/or female subjects, between 18 and 79 years of age, inclusive. * Body weight between 50.0 and 115.0 kg, inclusive, if male, and between 40.0 and 100.0 kg, inclusive, if female, body mass index between 18.0 and 34.9 kg/m2, inclusive * Normal electroc...

Countries:United States
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Frequently asked questions about Venglustat GZ/SAR402671

What is Venglustat GZ/SAR402671 used for?

Venglustat GZ/SAR402671 is an investigational small molecule being studied in nephrology. It is being evaluated in healthy volunteers and in patients with autosomal dominant polycystic kidney disease. The drug is currently in Phase 1 clinical development and is not approved for any use.

Who makes Venglustat GZ/SAR402671?

Venglustat GZ/SAR402671 is being developed by Sanofi, a company traded under the ticker SNY. The drug is in Phase 1 clinical development for nephrology indications, including autosomal dominant polycystic kidney disease.

What phase is Venglustat GZ/SAR402671 in?

Venglustat GZ/SAR402671 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received FDA designations including breakthrough therapy, fast track, orphan drug, and priority review.

What clinical trials is Venglustat GZ/SAR402671 in?

Venglustat GZ/SAR402671 has one completed Phase 1 clinical trial, NCT03687554, titled "Effect of Venglustat in Patients With Renal Impairment." The trial enrolled 24 participants in the United States, including healthy volunteers and patients with autosomal dominant polycystic kidney disease.

Is Venglustat GZ/SAR402671 the same as SAR402671?

Yes, Venglustat GZ/SAR402671 is also known as SAR402671. The drug is being developed by Sanofi for nephrology indications and is currently in Phase 1 clinical development.