A Phase I, Single-Center, Open-label, Single Dose Pharmacokinetic and Tolerability Study of GZ402671 in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
Sponsor study identifier
Secondary identifiers
OTHER · UTN
interventional
24
1 country
1
Study Start
October 5, 2018
Actual (reported)Primary Completion
February 27, 2019
Actual (reported)Study Completion
February 27, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 27, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2018
Actual (reported)September 27, 2018
Actual (reported)October 5, 2018
Actual (reported)February 27, 2019
Actual (reported)February 27, 2019
Actual (reported)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
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
Single dose of Venglustat is given, orally under fasting conditions
Pharmaceutical form: Hard Capsule Route of administration: Oral
Investigational Site Number 8400001
Miami, Florida, 33014, United States
Clinical Sciences & Operations
Sanofi
24 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2018
First Posted
September 27, 2018
Study Start
October 5, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 27, 2019
Actual (reported)Study Completion
February 27, 2019
Actual (reported)Last Updated
April 25, 2022
Record last verified: 2022-04
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Source: ClinicalTrials.gov.
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