NCT05835180

A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

A Phase I, Open-label, Pharmacokinetic Study of TVB-2640 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sagimet Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.

Conditions

• Non-alcoholic Steatohepatitis
• Hepatic Impairment
• Cirrhosis

Interventions

Type	Name	Description
DRUG	TVB-2640 - 50 mg	TVB-2640 -50 mg administered orally once daily

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-12-18
• Completion: 2023-12-18
• First posted: 2023-04-28
• Last updated: 2023-12-26

Locations

3 sites across 2 countries: United States, Hungary

Regulatory

• FDA-regulated drug study