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NCT05835180 · ClinicalTrials.gov registry record · Phase 1
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 1 study, sponsored by Sagimet Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT05835180: Completed Phase 1 study, sponsored by Sagimet Biosciences.
NCT05835180 is a Phase 1 study that has completed, run by Sagimet Biosciences. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05835180, a Phase 1 study, has completed, sponsored by Sagimet Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
Total TVB-2640 plasma concentration-time curve during a dosing interval at steady-state
Interventions
- DRUG TVB-2640 - 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2023-12-18 |
| Phase | Phase 1 |
What the finished NCT05835180 record still lists
NCT05835180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which TVB-2640 - 50 mg is the first listed.
NCT05835180 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05835180 about?
NCT05835180 is a clinical study titled "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". 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.
What is the current status of trial NCT05835180?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2023-05-01. Estimated completion is 2023-12-18.
What interventions are being tested in trial NCT05835180?
The interventions under investigation include: TVB-2640 - 50 mg (DRUG).
Who is sponsoring clinical trial NCT05835180?
This trial is sponsored by Sagimet Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05835180's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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