Effect of Venglustat in Patients With Renal Impairment

NCT03687554 | Completed Phase 1 FDA Drug

• 2 other identifiers: POP14499U1111-1205-3215
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics (PK) of Venglustat following a single dose. Secondary Objective: To assess the tolerability of Venglustat given as a single dose in subjects with mild, moderate and severe renal impairment in comparison with matched subjects with normal renal function.

Conditions

Healthy Volunteers; Polycystic Kidney, Autosomal Dominant

Outcome Measures

Primary Outcomes (1)

• Assessment of pharmacokinetic (PK) parameters of Venglustat: Area under the curve (AUC)

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

  Day 1 to Day 10

Secondary Outcomes (13)

• 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

• Venglustat plasma pharmacokinetic (PK) parameter: unbound AUC

  Day 1 to Day 10

• Venglustat plasma pharmacokinetic (PK) parameter: CL/F

  Day 1 to Day 10

Study Arms (1)

Venglustat

EXPERIMENTAL

Single dose of Venglustat is given, orally under fasting conditions

Drug: Venglustat GZ/SAR402671

Interventions

Venglustat GZ/SAR402671 DRUG

Pharmaceutical form: Hard Capsule Route of administration: Oral

Venglustat

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 electrocardiogram (ECG)
• Having given written informed consent prior to undertaking any study-related procedure
• Not under any administrative or legal supervision
• Specific for subjects with renal impairment:
• Stable chronic renal impairment
• Vital signs and laboratory parameters within acceptable range for subjects with renal impairment
• Specific for matched healthy subjects:
• Normal renal function
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical exam)
• Normal vital signs and laboratory parameters

You may not qualify if:

• 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, or asymptomatic postural hypotension judged clinically relevant by the Investigator
• 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)
• Positive result on urine drug screen or plasma alcohol test
• Active hepatitis, hepatic insufficiency
• If female, pregnancy \[defined as positive β-Human Chorionic Gonadotropin (β-HCG) blood test\], breast-feeding
• Specific for subjects with renal impairment:
• Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
• Acute renal failure (de novo or superimposed on preexisting chronic renal impairment), nephrotic syndrome
• History of or current hematuria of urologic origin that limits the subject's participation in the study
• Subjects requiring dialysis during the study
• Specific for matched healthy controls:
• \- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

Investigational Site Number 8400001

Miami, Florida, 33014, United States

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

venglustat

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: October 5, 2018
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)