NCT06421714

A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants

A Phase I, Single-Center, Open-Label, Two-Period, Single Sequence, Two Treatment Drug-Drug Interaction Study of GZ/SAR402671 (Venglustat) and Itraconazole in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess in healthy adult male participants the effects of itraconazole on the pharmacokinetics of venglustat and to assess the safety and tolerability of venglustat with and without coadministration of itraconazole. The maximum duration for participants from screening is between 32 to 62 days.

Detailed description

Total study duration for participants is up to 62 days including screening up to 28 days, 1 day of treatment in period 1, washout of 7 days, 13 days of treatment in period 2, and follow up period 10-14 days after last dose.

Conditions

• Healthy Volunteers

Interventions

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

Timeline

• Start date: 2018-08-16
• Primary completion: 2018-10-14
• Completion: 2018-10-14
• First posted: 2024-05-20
• Last updated: 2024-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study