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NCT04849650 · ClinicalTrials.gov registry record · Phase 1
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
A Phase 1 study, sponsored by Acacia Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04849650: Completed Phase 1 study, sponsored by Acacia Pharma.
NCT04849650 is a Phase 1 study that has completed, run by Acacia Pharma. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04849650, a Phase 1 study, has completed, sponsored by Acacia Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease. In addition it is important to understand how well tolerated Amisulpride is in this patient population. Healthy adults will be studied to provide a comparison.
Primary Outcome
Amisulpride plasma exposure after a single IV dose measured as the area under the concentration-time curve (AUC) between study drug administration and the time at which the following-day oral dose of Amisulpride is given
Interventions
- DRUG Amisulpride IV
- DRUG Amisulpride Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-06-03 |
| Est. Completion | 2021-10-30 |
| Phase | Phase 1 |
What the finished NCT04849650 record still lists
NCT04849650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Amisulpride IV is the first listed.
NCT04849650 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04849650 about?
NCT04849650 is a clinical study titled "PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment". The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease. In addition it is important to understand how well tolerated Amisulpride is in this patient po...
What is the current status of trial NCT04849650?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-06-03. Estimated completion is 2021-10-30.
What interventions are being tested in trial NCT04849650?
The interventions under investigation include: Amisulpride IV (DRUG), Amisulpride Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04849650?
This trial is sponsored by Acacia Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04849650's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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