Assessment of the Biodistribution and Safety of 123-I MZINT in Healthy Subjects and Parkinson Disease Patients

NCT00427674 | Terminated Phase 1 DMC

• 1 other identifier: _mZINT_001/002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The overall plan of this project is to evaluate \[123I\] mZINT as a tool to assess SERT density in humans. This protocol will be completed in three parts. In Part A serial dynamic SPECT will be acquired after injection of \[123I\] mZINT in healthy controls to assess regional brain uptake in human subjects. If Part A demonstrates robust brain region specific uptake, then Part B - additional studies in healthy subjects to assess biodistribution, and Part C - studies in PD subjects to compare regional uptake to healthy controls, will be completed.

Conditions

Parkinson Disease

Keywords

Parkinson; Imaging

Outcome Measures

Primary Outcomes (4)

• Measurement of 123-mZINT brain uptake and distribution

  1 yr

• pharmacokinetics of brain uptake and washout

  1 year

• measurement of biodistribution and radiation absorbed dose of 123-I MZINT in the brain SERT

  1 yr

• Evaluation for reduction in midbrain and/or striatal SERT density using 123-I MZINT.

  1 yr

Study Arms (1)

injection of 5 mCi of 123-I mZINT

EXPERIMENTAL

Drug: [123I] mZINT injection and serial dynamic SPECT imaging

Interventions

[123I] mZINT injection and serial dynamic SPECT imaging DRUG

Following bolus intravenous injection of 5 mCi of 123-I mZINT 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 mZINT and metabolites will be assessed. Safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKG.

injection of 5 mCi of 123-I mZINT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Health Control:
• The subject is aged 18-70.
• Written informed consent is obtained.
• The participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
• For females, non-child bearing potential or negative urine pregnancy test on day of \[123I\] mZINT injection.
• Willingness to comply with the study protocol
• Parkinson disease:
• The subject is aged 18-70.
• Participants have a clinical diagnosis (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) of idiopathic Parkinson's disease.
• Hoehn and Yahr stages \< 3.
• Written informed consent is obtained.
• The participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
• For females, non-child bearing potential or negative urine pregnancy test on day of \[123I\] mZINT injection.
• Willingness to comply with the study protocol

You may not qualify if:

• All Subjects will be excluded from participation for the following reasons:
• 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 serotonin such as antidepressants including sertraline, fluoxetine, fluvoxamine, venlafaxine.
• The participant has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) {American Psychiatric Association, 1994 #2} within the past 2 years.
• Pregnancy

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• Molecular NeuroImaging: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Iodine-123

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• John P Seibyl, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 6, 2010

Record last verified: 2010-10

Locations

US (1)