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NCT05495581 · ClinicalTrials.gov registry record · Phase 1
A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well
A Phase 1 study of Healthy Volunteers and Renal Impairment, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 4
- Study locations
NCT05495581: Completed Phase 1 study of Healthy Volunteers and Renal Impairment, sponsored by Astellas Pharma Global Development.
NCT05495581 is a Phase 1 study of Healthy Volunteers and Renal Impairment that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 28 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05495581, a Phase 1 study of Healthy Volunteers and Renal Impairment, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 4
- Study locations
Study Summary
The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. ASP5354 is a potential new medical dye to help surgeons clearly see the ureter during surgery. ASP5354 is injected into the body and is detected by a type of camera called near infrared fluoroscopy, or NIR-F for short. Together they show live images of the ureter during surgery. Before ASP5354 is available as a medical dye, the researchers need to understand how it affects the body. In this study, the researchers will check how ASP5354 affects the body in adults up to 75 years old. The main aim is to learn how ASP5354 is processed by the body in people whose kidneys do not work well compared to healthy people. There will be 4 groups of people with different levels of how well their kidneys work. This study will include a 3-night stay in a clinical research unit. People will be admitted to the clinic the day before they receive the ASP5354 injection. The study doctor will take their medical history. People will have an ECG to measure their heart rhythm, a medical examination, and will have their vital signs checked (pulse rate, body temperature and blood pressure). They will also give blood and urine samples for laboratory tests. For some women, this will include a pregnancy test. People will need to fast for several hours before receiving the injection. The next day, people will receive 1 injection of ASP5354. They will continue to fast for a few hours afterwards. They will have an ECG and will have their vital signs checked. They will also give blood and urine samples for laboratory tests and the study doctors will check for medical problems. During the next 2 days, people will give more blood and urine samples and the study doctors will check for medical problems. On the last day, people will also have their vital signs checked. If the
Primary Outcome
AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.
Conditions Studied
Interventions
- DRUG pudexacianinium chloride
Study Locations (4)
Alabama
- Pinnacle Research Group - Anniston
California
- Orange County Research Center - Tustin
Florida
- Advanced Pharma CR, LLC - Miami
Tokyo
- Sekino Clinical Pharmacology Clinic - Toshima-ku
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2023-05-08 |
| Phase | Phase 1 |
What the finished NCT05495581 record still lists
NCT05495581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which pudexacianinium chloride is the first listed.
NCT05495581 reports a single indexed study location in Alabama, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05495581 about?
NCT05495581 is a clinical study titled "A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well". The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. ASP5354 is a potential new medical dye to help surgeons clearly see the ...
What is the current status of trial NCT05495581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2022-08-25. Estimated completion is 2023-05-08.
What conditions does trial NCT05495581 study?
This clinical trial studies the following conditions: Healthy Volunteers, Renal Impairment.
What interventions are being tested in trial NCT05495581?
The interventions under investigation include: pudexacianinium chloride (DRUG).
Who is sponsoring clinical trial NCT05495581?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05495581 being conducted?
This trial has 4 study locations across Alabama, California, Florida, Tokyo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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