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NCT04993157 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT04993157 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 54 participants.
The verdict
NCT04993157, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy participants.The information obtained in this study will help to determine whether dosage adjustment for FIA586 is necessary in patients with advanced liver fibrosis who have mild to moderate HI.
Interventions
- DRUG FIA586
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-12-10 |
| Est. Completion | 2022-06-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04993157
The ClinicalTrials.gov registry entry for NCT04993157 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which FIA586 is the first listed.
NCT04993157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04993157 about?
NCT04993157 is a clinical study titled "Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment". This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy participants.The information obtained in this study will help to determine w...
What is the current status of trial NCT04993157?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2021-12-10. Estimated completion is 2022-06-28.
What interventions are being tested in trial NCT04993157?
The interventions under investigation include: FIA586 (DRUG).
Who is sponsoring clinical trial NCT04993157?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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