Biodistribution and Safety of a Radiopharmaceutical in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Molecular NeuroImaging
Information provided by (Responsible Party):
John Seibyl, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00316797
First received: April 19, 2006
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Neurodegenerative Diseases
Drug: 123-I INER
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase 1 Assessment of the Biodistribution and Safety of 123-I INER in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • Assess the biodistribution and metabolic rate of 123-I INER for determination of radiation absorbed dose estimates. [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess 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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: April 2006
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 123-I INER
To assess 123-I INER
Drug: 123-I INER
Serial whole body planar imaging in the anterior and posterior projection will be performed at 1 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, and 18-24h following injection of 5 mCi of 123-I INER. Venous blood data will be acquired at each imaging time point. In addition a 24 hour urine collection will commence following radiotracer injection and urine sampled in five collections every 4 hours collection for first sixteen hours (4 collections), then one collection from 16 to 24 h. Whole body and source organs uptake will be analyzed on anterior and posterior images for calculating the radiation absorbed doses to organs using the MIRD method as described previously (Seibyl, et al, 1993). Plasma and urine metabolites will be characterized and safety assessments obtained.

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 inclusion/exclusion 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316797

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Molecular NeuroImaging
Investigators
Principal Investigator: John Seibyl, MD Institute for Neurodegenerative Disorders
  More Information

Additional Information:
Publications:
Responsible Party: John Seibyl, MD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00316797     History of Changes
Other Study ID Numbers: H01_INER_001/002
Study First Received: April 19, 2006
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
SPECT
Nuclear Medicine

Additional relevant MeSH terms:
Neurodegenerative Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014