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NCT06418620

A Study of the Safety, Tolerability, and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants

Phase 1, Open Label, Randomized, 3-sequence, 3-period, Single Dose Study Assessing the Effect of Food on the Bioavailability of Venglustat Tablet and Comparing the Relative Bioavailability of Venglustat Tablet Chewed Versus Tablet Swallowed Whole
Sanofi·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
Sanofi
Location
Saint Paul, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jun 18, 2020
End date
Aug 07, 2020
Enrollment
9 participants
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
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
NCT06418620
Type
Non-Device Trial
About this record

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.

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.