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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: Completed Phase 1 study, sponsored by Theravance Biopharma.
NCT04200573 is a Phase 1 study that has completed, run by Theravance Biopharma. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Estimation of Area under the concentration-time curve, from time zero to the last measured time point
Interventions
- DRUG Ampreloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-01-13 |
| Est. Completion | 2021-08-19 |
| Phase | Phase 1 |
What the finished NCT04200573 record still lists
NCT04200573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Ampreloxetine is the first listed.
NCT04200573 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04200573's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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