drugset / Trial / 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
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-05-01
- Primary completion
- 2023-12-18
- Completion
- 2023-12-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denifanstat | Small molecule | 50 mg | Oral |