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NCT05117294 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT05117294 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 13 participants.
The verdict
NCT05117294, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367. The main aim of the study is to learn how ASP0367 is processed by the body in these different groups of people. This study will be in 2 parts. Part 2 will only happen if the results between the 2 groups are different in Part 1. In each part, people in the study will stay in a research unit for 6 days and 5 nights. Later, they will return to the research unit for 1 check-up. In Part 1, people whose kidneys work normally and people whose kidneys work very poorly (severe renal impairment) can take part. If Part 2 happens, people whose kidneys work normally and people whose kidneys do not work well (mild or moderate renal impairment) can take part. In both parts of the study, people who can take part will be admitted to the research unit. The next day they will take tablets of ASP0367 just once. People will give blood and urine samples at various times during their stay. They will have their vital signs (heart rate and blood pressure) checked regularly. People will also have ECGs to check their heart rhythm. They will be asked if they have any medical problems. After 6 days, provided all the checks have been done and there are no medical problems, people in the study will leave the research unit. People will return to the research unit for 1 check-up. This will be between 9 and 11 days after their last blood sample was taken during their previous stay in the unit. The check-up will include a physical exam, a check of people's vital signs (heart rate and blood pressure), and blood tests. Also, people will have an ECG and be asked if they have had any medical problems.
Interventions
- DRUG Bocidelpar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-12-21 |
| Est. Completion | 2022-11-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05117294
The ClinicalTrials.gov registry entry for NCT05117294 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bocidelpar is the first listed.
NCT05117294 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05117294 about?
NCT05117294 is a clinical study titled "A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People". This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367. The main aim of the study is to learn how ASP0367 is processed by the body in these different grou...
What is the current status of trial NCT05117294?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-12-21. Estimated completion is 2022-11-22.
What interventions are being tested in trial NCT05117294?
The interventions under investigation include: Bocidelpar (DRUG).
Who is sponsoring clinical trial NCT05117294?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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