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NCT05217901 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How [14C]ASP0367 is Processed by the Body in Healthy Men
A Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT05217901: Completed Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
NCT05217901 is a Phase 1 study of Healthy Volunteers that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 9 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05217901, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
ASP0367 is a potential new treatment for people with Duchenne Muscular Dystrophy and Mitochondrial Myopathies. Before ASP0367 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This study is in healthy men. The main aim of this study is to learn how ASP0367 is processed by and acts upon the bodies of healthy men. To do this, \[14C\] which is a certain chemical (called a tracer, or radionuclide) has been added to ASP0367. \[14C\] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. \[14C\] will be picked up by a scanner and will be used to follow ASP0367 through the body. \[14C\]ASP0367 will be a liquid. During the study, the men who take part will stay in the clinic for 6 days and 5 nights. Some men may need to stay up to an extra 7 days in the clinic. This will happen if there is a medical reason or if they still have traces of radiation in their blood, urine or feces. On the day before they drink \[14C\]ASP0367, the men will be asked about their medical history, have a medical examination, and have their vital signs checked (blood pressure and pulse). They will also have an ECG to check their heart rhythm. They will give urine, stool and blood samples for laboratory tests. They will also be asked if they have had any medical problems. The men will fast for 10 hours or more before drinking \[14C\]ASP0367 and for 4 hours afterwards. They will only have one drink of \[14C\]ASP0367. They will need to lie still for 4 hours after drinking \[14C\]ASP0367. They will have their vital signs checked and give urine, stool and blood samples for laboratory tests. Then, they will give urine, stool and blood samples every day until they leave the clinic. They will also be asked every day if they have had any medical problems. The day after they drink \[14C\]ASP0367, the men will also have an ECG. On the last clinic day, the men will also h
Primary Outcome
AUCinf will be recorded from PK whole blood samples collected.
Conditions Studied
Interventions
- DRUG 14C-labeled ASP0367
Study Locations (1)
Wisconsin
- Labcorp CRU - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-01-21 |
| Est. Completion | 2022-05-09 |
| Phase | Phase 1 |
What the finished NCT05217901 record still lists
NCT05217901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which 14C-labeled ASP0367 is the first listed.
NCT05217901 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05217901 about?
NCT05217901 is a clinical study titled "A Study to Learn How [14C]ASP0367 is Processed by the Body in Healthy Men". ASP0367 is a potential new treatment for people with Duchenne Muscular Dystrophy and Mitochondrial Myopathies. Before ASP0367 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This study is in healthy men. The main aim of this study is to...
What is the current status of trial NCT05217901?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2022-01-21. Estimated completion is 2022-05-09.
What conditions does trial NCT05217901 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05217901?
The interventions under investigation include: 14C-labeled ASP0367 (DRUG).
Who is sponsoring clinical trial NCT05217901?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05217901 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05217901's enrollment target sits among peer trials
9 267th of 283 higher than 16 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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