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NCT03557658 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
A Phase 1 study, sponsored by Theracos.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03557658: Completed Phase 1 study, sponsored by Theracos.
NCT03557658 is a Phase 1 study that has completed, run by Theracos. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03557658, a Phase 1 study, has completed, sponsored by Theracos.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the drug exposure and drug effects on subjects with moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg. The study will also evaluate how safe the study drug is and how well the study drug is tolerated in subjects with moderate hepatic impairment.
Primary Outcome
Whole venous blood samples of 6mL were collected from a peripheral vein prior to dosing and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
Interventions
- DRUG Bexagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-07-26 |
| Est. Completion | 2018-12-26 |
| Phase | Phase 1 |
What the finished NCT03557658 record still lists
NCT03557658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Bexagliflozin is the first listed.
NCT03557658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03557658 about?
NCT03557658 is a clinical study titled "Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment". The purpose of this study is to examine the drug exposure and drug effects on subjects with moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg. The study will also evaluate how safe the study drug is and how well the study drug is tolerated in subjects with moderate ...
What is the current status of trial NCT03557658?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-07-26. Estimated completion is 2018-12-26.
What interventions are being tested in trial NCT03557658?
The interventions under investigation include: Bexagliflozin (DRUG).
Who is sponsoring clinical trial NCT03557658?
This trial is sponsored by Theracos, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03557658's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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