A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants - Trial NCT06418607
Access comprehensive clinical trial information for NCT06418607 through Pure Global AI's free database. This Phase 1 trial is sponsored by Sanofi and is currently Completed. The study focuses on Healthy Volunteers. Target enrollment is 65 participants.
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Study Focus
Sponsor & Location
Sanofi
Timeline & Enrollment
Phase 1
Jun 23, 2020
Jul 13, 2020
Primary Outcome
Maximum plasma concentration observed (Cmax) of venglustat,Area under the plasma concentration versus time curve calculated from time zero to the real time (tlast) (AUClast) of venglustat,Area under the plasma concentration versus time curve (AUC) of venglustat
Summary
The purpose of this study is to assess the bioequivalent effect of venglustat in tablet and
 hard capsule form when give with water under fasting conditions. Also, to evaluate the safety
 and tolerability of a single dose tablet and hard capsule of venglustat (swallowed whole)
 under fasting conditions in healthy adult participants. The maximum duration for participants
 from screening is up to 47 days.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06418607
Non-Device Trial