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NCT04200573 · ClinicalTrials.gov registry record · Phase 1
Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855
A Phase 1 study, sponsored by Theravance Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT04200573 is a Phase 1 study that has completed, run by Theravance Biopharma. The registered enrollment target is 31 participants.
The verdict
NCT04200573, a Phase 1 study, has completed, sponsored by Theravance Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal hepatic function.
Interventions
- DRUG Ampreloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-01-13 |
| Est. Completion | 2021-08-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04200573
The ClinicalTrials.gov registry entry for NCT04200573 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theravance Biopharma, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ampreloxetine is the first listed.
NCT04200573 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04200573 about?
NCT04200573 is a clinical study titled "Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855". An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal hepatic function.
What is the current status of trial NCT04200573?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2020-01-13. Estimated completion is 2021-08-19.
What interventions are being tested in trial NCT04200573?
The interventions under investigation include: Ampreloxetine (DRUG).
Who is sponsoring clinical trial NCT04200573?
This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
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