A Study of Florbetapir (18F) in Japanese Healthy Volunteers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: florbetapir (18F)
Intervention description: IV injection, 370 MBq (10mCi), single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed
      throughout the body of Japanese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Are Japanese cognitively normal healthy males or females at least 45 years of age;

          2. Give informed consent; and

          3. Are able to lie still on the imaging table for periods up to one hour.

        Exclusion Criteria:

          1. Have had radiation exposure (PET, SPECT or CT scans) for experimental purposes within
             the last year;

          2. Are claustrophobic or otherwise unable to tolerate the imaging procedure;

          3. Have medical conditions or surgical history that would confound evaluation of
             dosimetry (e.g., liver disease, colectomy etc.);

          4. Have current clinically significant cardiovascular disease. Clinically significant
             cardiovascular disease usually includes one or more of the following:

               1. cardiac surgery or myocardial infarction within the last 6 months;

               2. unstable angina;

               3. coronary artery disease that required a change in medication within the last 3
                  months;

               4. decompensated congestive heart failure;

               5. significant cardiac arrhythmia or conduction disturbance, particularly those
                  resulting in atrial or ventricular fibrillation, or causing syncope, near
                  syncope, or other alterations in mental status;

               6. severe mitral or aortic valvular disease;

               7. uncontrolled high blood pressure;

               8. congenital heart disease;

               9. clinically significant abnormal result on ECG, including but not limited to
                  QTc>450 msec; Before enrolling a patient with any evidence of the above
                  conditions, the investigator must contact the sponsor;

          5. Have current clinically significant medical comorbidities, as indicated by history,
             physical exam, or laboratory evaluations that might pose a potential safety risk,
             interfere with the absorption or metabolism of the study medication or limit
             interpretation of the trial results. These include but are not limited to clinically
             significant hepatic, renal, pulmonary, metabolic or endocrine disease, cancer;

          6. Have a history of drug or alcohol abuse within the last year, or prior prolonged
             history of abuse;

          7. Have a history of epilepsy or convulsions, except for febrile convulsions during
             childhood;

          8. Have clinically significant infectious disease, including AIDS or HIV infection or
             previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2;

          9. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to
             the study imaging session;

         10. Are females of childbearing potential who are not surgically sterile, not refraining
             from sexual activity or not using reliable methods of contraception. Females of
             childbearing potential must not be pregnant (negative serum β-HCG at the time of
             screening) or breastfeeding at screening. Females must agree to avoid becoming
             pregnant, and must agree to refrain from sexual activity or to use reliable methods of
             contraception such as prescribed birth control or IUD for 24 hours following
             administration of florbetapir (18F);

         11. Have a history of severe drug allergy or hypersensitivity;

         12. Received an investigational medication within the last 30 days or who have
             participated in a clinical trial with any experimental medication in the last 30 days.

             Additionally, the time between the last dose of the previous experimental medication
             and enrollment (completion of screening assessments) must be at least equal to 5 times
             the terminal half-life of the previous experimental medication;

         13. Have known hypersensitivity to alcohol; and

         14. In the opinion of the investigator, are otherwise unsuitable for a study of this type.