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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 is a Phase 1 study that has completed, run by Sagimet Biosciences. The registered enrollment target is 48 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05835180
The ClinicalTrials.gov registry entry for NCT05835180 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sagimet Biosciences, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TVB-2640 - 50 mg is the first listed.
NCT05835180 reports 0 study locations.
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.
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