Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316797
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2006-04-19
Brief Title:
Biodistribution and Safety of a Radiopharmaceutical in Healthy Subjects
Sponsor:
Institute for Neurodegenerative Disorders
Organization:
Institute for Neurodegenerative Disorders
Study Overview
Official Title:
Phase 1 Assessment of the Biodistribution and Safety of 123-I INER in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 include review of medical and psychiatric history review of medications physical examination including height and body weight vital sign measurements review of inclusionexclusion criteria clinical laboratory testing serum chemistries CBC urinalysis urinary drug screen urine pregnancy test for females of childbearing potential and electrocardiogram in preparation for the imaging study
Part A Four healthy subjects will each receive one injection of 123-I INER Serial whole body planar imaging in the anterior and posterior projection will be performed over the 8-9 hour period following injection of 5 mCi of 123-I INER and again at 18-24 hours following injection Venous blood data will be acquired at each imaging time point In addition a 24 hour urine collection will commence following radiotracer injection Whole body and source organs uptake will be analyzed on anterior and posterior images for calculating the radiation absorbed doses to organs Plasma and urine metabolites will be characterized and safety assessments obtained Serial safety assessments will include vital signs serum chemistries CBC urinalysis and EKGs
Part B Six healthy subjects will each receive one injection of 123-I INER Following bolus intravenous injection of 5 mCi of 123-I INER over 15 seconds serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity Venous blood measures will be obtained with each acquisition and characterization of 123-I INER and metabolites will be assessed Safety assessments will include vital signs serum chemistries CBC urinalysis and EKGs
Part A Four healthy subjects will each receive one injection of 123-I INER Serial whole body planar imaging in the anterior and posterior projection will be performed over the 8-9 hour period following injection of 5 mCi of 123-I INER and again at 18-24 hours following injection Venous blood data will be acquired at each imaging time point In addition a 24 hour urine collection will commence following radiotracer injection Whole body and source organs uptake will be analyzed on anterior and posterior images for calculating the radiation absorbed doses to organs Plasma and urine metabolites will be characterized and safety assessments obtained Serial safety assessments will include vital signs serum chemistries CBC urinalysis and EKGs
Part B Six healthy subjects will each receive one injection of 123-I INER Following bolus intravenous injection of 5 mCi of 123-I INER over 15 seconds serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity Venous blood measures will be obtained with each acquisition and characterization of 123-I INER and metabolites will be assessed Safety assessments will include vital signs serum chemistries CBC urinalysis and EKGs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None