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NCT06418607

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

Phase 1, Open Label, Randomized, Single-center, 2-sequence, 2-period, 2 Treatment Single Dose Crossover Bioequivalence Study Comparing Venglustat Tablet Formulation (Test) to Hard Capsule Formulation (Reference)
Sanofi·Phase 1·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Healthy Volunteers
Drug/Device/Intervention
Venglustat
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sanofi
Location
Miami,Saint Paul, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jun 23, 2020
End date
Jul 13, 2020
Enrollment
65 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 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
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
NCT06418607
Type
Non-Device Trial
About this record

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.

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.