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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 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.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05217901
The ClinicalTrials.gov registry entry for NCT05217901 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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