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NCT05393076 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT05393076 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 8 participants.
The verdict
NCT05393076, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function. All participants in both cohorts (moderate hepatic impairment and matched healthy controls) will receive a single dose of the study drug, linerixibat. The purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) and safety of linerixibat.
Interventions
- DRUG Linerixibat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-07-19 |
| Est. Completion | 2022-12-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05393076
The ClinicalTrials.gov registry entry for NCT05393076 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Linerixibat is the first listed.
NCT05393076 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05393076 about?
NCT05393076 is a clinical study titled "Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls". This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function. All participants in both cohorts (moderate hepatic impairment and matched healthy controls) will rece...
What is the current status of trial NCT05393076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-07-19. Estimated completion is 2022-12-06.
What interventions are being tested in trial NCT05393076?
The interventions under investigation include: Linerixibat (DRUG).
Who is sponsoring clinical trial NCT05393076?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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