A Study of the Safety, Tolerability, and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants - Trial NCT06418620
Access comprehensive clinical trial information for NCT06418620 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 9 participants.
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Study Focus
Sponsor & Location
Sanofi
Timeline & Enrollment
Phase 1
Jun 18, 2020
Aug 07, 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 effect of food on the bioavailability of
 venglustat and to assess the relative bioavailability of venglustat tablet swallowed whole
 with water versus a tablet chewed and then swallowed without water. Also, to evaluate the
 safety and tolerability of a single dose tablet of venglustat under fed (swallowed whole) and
 fasted (swallowed whole or chewed) conditions in healthy adult participants. The maximum
 duration for participants from screening is up to 63 days.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06418620
Non-Device Trial