Status:
COMPLETED
Biodistribution and Safety of a Radiopharmaceutical in Healthy Subjects
Lead Sponsor:
Institute for Neurodegenerative Disorders
Collaborating Sponsors:
Molecular NeuroImaging
Conditions:
Neurodegenerative Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 a...
Detailed Description
All subjects will receive a full physical examination at IND to determine study eligibility. Written informed consent will be obtained prior to any study procedures. The screening procedures will incl...
Eligibility Criteria
Inclusion
- The subject is aged 18-65.
- Written informed consent is obtained.
- The subject has a negative history of neurological or psychiatric illness based on evaluation by a research physician.
- For females, non-child bearing potential or negative urine pregnancy test on day of \[123I\] INER injection.
Exclusion
- The subject has a clinically significant clinical laboratory values abnormality, and/or medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Use of all prescription drugs or non-prescriptions drugs that may effect norepinephrine such as cold remedies (for 2 weeks prior to injection).
- Pregnancy
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00316797
Start Date
April 1 2006
End Date
January 1 2014
Last Update
April 10 2014
Active Locations (1)
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1
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510