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NCT05167526 · ClinicalTrials.gov registry record · Phase 1
A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT05167526 is a Phase 1 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 36 participants.
The verdict
NCT05167526, a Phase 1 study, was terminated before completion, sponsored by Astellas Pharma Global Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
ASP8731 is a potential new treatment for people with sickle cell disease. Before ASP8731 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. They do this to find a suitable dose and to check for potential medical problems from the treatment. This type of study usually includes healthy adults but can include people with the relevant condition. The main aim of this study is to learn if healthy adults have any medical problems after taking different doses of ASP8731. This study will be in 2 parts. In Part 1, different small groups of people will take lower to higher doses of ASP8731 or a placebo. In this study a placebo looks like ASP8731 but will not have any medicine in it. This is done to find suitable doses of ASP8731 and work out how often it should be taken. Some of this information will be used in Part 2 of the study. The first group will take the lowest dose of ASP8731 or the placebo. A medical expert panel will check the results from this group and decide which ASP8731 dose the next group can take. The panel will do this for each group until all groups have taken ASP8731 or until a suitable dose of ASP8731 has been reached. In Part 1, people will visit the study clinic 4 times. The first visit is to check if they can take part. People will be asked about their medical history, have a physical exam, and their vital signs checked (pulse rate, temperature, and blood pressure). Also, they will have an ECG to check their heart rhythm and have some blood samples taken for laboratory tests. For women this will include a pregnancy test. At the second visit, people will stay in the study clinic for a few days. In most groups, people will be picked to take either ASP8731 or the placebo by chance alone. They will fast before taking ASP8731 or the placebo. 1 group will take ASP8731 with food. No-one in that group will take the placebo. After taking ASP8731 or the placebo (or just ASP8731 with food), people in
Interventions
- DRUG ASP8731
- DRUG ASP8731 Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2022-11-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05167526
The ClinicalTrials.gov registry entry for NCT05167526 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 36 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 2 interventions - of which ASP8731 is the first listed.
NCT05167526 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05167526 about?
NCT05167526 is a clinical study titled "A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults". ASP8731 is a potential new treatment for people with sickle cell disease. Before ASP8731 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. They do this to find a suitable dose and to check for potential medical problems from the treatment....
What is the current status of trial NCT05167526?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-03-07. Estimated completion is 2022-11-10.
What interventions are being tested in trial NCT05167526?
The interventions under investigation include: ASP8731 (DRUG), ASP8731 Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT05167526?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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