A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function
Completed · Phase 1 · NCT05718258
Conditions: Hepatic Function Abnormal
At a glance
- Research payments reported, 2025
- $32,199
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 26
About the trial
- Sponsor
- Sanofi
- Tested
- Venglustat (GZ402671) (drug)
- Dates
- Started 2023-01-18; completion 2024-01-29
- Results posted
- Not yet
This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat. The purpose of this study is to assess the effect of mild, moderate, and severe hepatic impairment on PK, safety, and tolerability of venglustat compared with normal hepatic function in male and female participants aged 18 to 79 years. Study details include: * The total study duration per participant will be up to 42 days, including up to 21 days for screening and approximately 21 days from institutionalization to the end of study (EOS). * Institutionalization is mandatory until the activities on D5 have …
From ClinicalTrials.gov, last updated 2025-09-15. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $32,199 in research payments for this study in 2025 (3 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Prism Clinical Research $32,199
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.