Overview

Biodistribution and Safety of a Radiopharmaceutical in Healthy Subjects

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Institute for Neurodegenerative Disorders
Collaborator:
Molecular NeuroImaging
Treatments:
Radiopharmaceuticals
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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