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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Total study duration for participants is up to 63 days including screening up to 27 days, 1 day of treatment in period 1 of 7 days, washout of 3 days, 1 day of treatment in period 2 of 7 days, washout of 3 days, 1 day of treatment in period 3 of 7 days, 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

Timeline

• Start date: 2020-06-18
• Primary completion: 2020-08-07
• Completion: 2020-08-07
• First posted: 2024-05-17
• Last updated: 2024-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study