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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 is a Phase 1 study that has completed, run by Institute for Neurodegenerative Disorders. The registered enrollment target is 35 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00316797
The ClinicalTrials.gov registry entry for NCT00316797 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institute for Neurodegenerative Disorders, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 123-I INER is the first listed.
NCT00316797 reports 0 study locations.
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.
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