Biodistribution and Safety of a Radiopharmaceutical in Healthy Subjects
Condition: Neurodegenerative Diseases
MeSH terms: Neurodegenerative Diseases
Study type: Interventional
Phase: Phase 1

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
      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.
    

Intervention name(s): 123-I INER
Intervention type(s): Drug
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: SPECT; Nuclear Medicine