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NCT06418607 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy Volunteers, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target
2
Study locations

NCT06418607 is a Phase 1 study of Healthy Volunteers that has completed, run by Sanofi. The registered enrollment target is 65 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT06418607, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target
2
Study locations

Study 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.

Conditions Studied

Healthy Volunteers

Interventions

  • DRUG Venglustat

Study Locations (2)

Florida

  • Clinical Pharmacology of Miami Site Number : 8400001 - Miami

Minnesota

  • Prism Research Site Number : 8400002 - Saint Paul

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2020-06-23
Est. Completion 2020-07-13
Phase Phase 1

Sponsor

Sanofi

713 total trials

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What the Registry Record Tells You About NCT06418607

The ClinicalTrials.gov registry entry for NCT06418607 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (87% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Venglustat is the first listed.

NCT06418607 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Minnesota.

Frequently Asked Questions

What is clinical trial NCT06418607 about?

NCT06418607 is a clinical study titled "A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants". 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...

What is the current status of trial NCT06418607?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2020-06-23. Estimated completion is 2020-07-13.

What conditions does trial NCT06418607 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT06418607?

The interventions under investigation include: Venglustat (DRUG).

Who is sponsoring clinical trial NCT06418607?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06418607 being conducted?

This trial has 2 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.