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NCT00316797 · ClinicalTrials.gov registry record · Phase 1
Biodistribution and Safety of a Radiopharmaceutical in Healthy Subjects
A Phase 1 study, sponsored by Institute for Neurodegenerative Disorders.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00316797: Completed Phase 1 study, sponsored by Institute for Neurodegenerative Disorders.
NCT00316797 is a Phase 1 study that has completed, run by Institute for Neurodegenerative Disorders. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00316797, a Phase 1 study, has completed, sponsored by Institute for Neurodegenerative Disorders.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The initial study of \[123I\] INER will be completed in two parts. Once Part A (Preliminary whole body biodistribution) is completed, Part B (Serial dynamic SPECT assessment of regional brain uptake and washout and plasma metabolite analysis to determine the brain penetrance and regional distribution and washout counts following 123-I INER injection) will commence. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, and a baseline physical and neurological evaluation.
Interventions
- DRUG 123-I INER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2006-04 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT00316797 record still lists
NCT00316797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which 123-I INER is the first listed.
NCT00316797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00316797 about?
NCT00316797 is a clinical study titled "Biodistribution and Safety of a Radiopharmaceutical in Healthy Subjects". The initial study of \[123I\] INER will be completed in two parts. Once Part A (Preliminary whole body biodistribution) is completed, Part B (Serial dynamic SPECT assessment of regional brain uptake and washout and plasma metabolite analysis to determine the brain penetrance and regional distributio...
What is the current status of trial NCT00316797?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2006-04. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00316797?
The interventions under investigation include: 123-I INER (DRUG).
Who is sponsoring clinical trial NCT00316797?
This trial is sponsored by Institute for Neurodegenerative Disorders, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00316797's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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