A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants - Trial NCT06421714
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.
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Study Focus
Sponsor & Location
Genzyme, a Sanofi Company
Sanofi
Timeline & Enrollment
Phase 1
Aug 16, 2018
Oct 14, 2018
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
Data Source
ClinicalTrials.gov
NCT06421714
Non-Device Trial