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

Completed · Phase 1

Conditions studied: Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis

In brief

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.

Key facts

Study ID

NCT05835180

Run by

Sagimet Biosciences Inc.

People needed

48

Starts

2023-05-01

Expected to finish

2023-12-18

Last updated by the study team

2023-12-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

Where it is running

• Thomas C. Marbury — Orlando, Florida, United States
• Eric J. Lawitz, MD — San Antonio, Texas, United States
• Geza Lakner — Kistarcsa, Hungary

Full record on ClinicalTrials.gov

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