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NCT06421714

A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants

A Phase I, Single-Center, Open-Label, Two-Period, Single Sequence, Two Treatment Drug-Drug Interaction Study of GZ/SAR402671 (Venglustat) and Itraconazole in Healthy Male Subjects
Genzyme, a Sanofi Company·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteers
Drug/Device/Intervention
Venglustat
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Genzyme, a Sanofi Company
Funder
Sanofi
Location
Austin, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Aug 16, 2018
End date
Oct 14, 2018
Enrollment
8 participants
Primary outcome

Area under the plasma concentration versus time curve (AUC) of venglustat,Area under the plasma concentration versus time curve calculated from time zero to the real time (tlast) (AUClast) of venglustat

Summary

The purpose of this study is to assess in healthy adult male participants the effects of
 itraconazole on the pharmacokinetics of venglustat and to assess the safety and tolerability
 of venglustat with and without coadministration of itraconazole. The maximum duration for
 participants from screening is between 32 to 62 days.

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06421714
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06421714 through Pure Global AI's free database. This Phase 1 trial is sponsored by Genzyme, a Sanofi Company and is currently Completed. The study focuses on Healthy Volunteers. Target enrollment is 8 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.