Biodistribution and Safety of a Radiopharmaceutical in Healthy Subjects

Completed · Phase 1

Conditions studied: Neurodegenerative Diseases

In brief

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.

Key facts

Study ID

NCT00316797

Run by

Institute for Neurodegenerative Disorders

People needed

35

Starts

2006-04-01

Expected to finish

2014-01-01

Last updated by the study team

2014-04-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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