A Study of Florbetapir (18F) in Japanese Healthy Volunteers

PET Whole Body Biodistribution Using Florbetapir (18F)

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

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: florbetapir (18F)

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kobe, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers; Cognitively normal, healthy volunteers at least 45 years of age.	Drug: florbetapir (18F); IV injection, 370 MBq (10mCi), single dose; Other Names: Amyvid; 18F-AV-45; Florbetapir F 18

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole Body Radiation Dosimetry	Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.	0-360 minutes

Collaborators and Investigators

• Sponsor: Avid Radiopharmaceuticals
• Collaborators: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 8, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

• Last Update Posted (Estimate): September 19, 2013
• Last Update Submitted That Met QC Criteria: July 16, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 18F-AV-45-J02; I6E-AV-AVBA (Other Identifier: Eli Lilly Japan)