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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Total study duration for participants is up to 47 days including screening up to 20 days, 1 day of treatment in period 1 of 8-10 days, 1 day of treatment in period 2 of 8 days and followed by a final observation over 7 days (+/- 2 days).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Venglustat	Pharmaceutical form:Tablet-Route of administration:Oral
DRUG	Venglustat	Pharmaceutical form:Hard Capsule-Route of administration:Oral

Timeline

• Start date: 2020-06-23
• Primary completion: 2020-07-13
• Completion: 2020-07-13
• First posted: 2024-05-17
• Last updated: 2024-05-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study