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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01660815
First received: August 7, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: florbetapir (18F)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET Whole Body Biodistribution Using Florbetapir (18F)

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Whole Body Radiation Dosimetry [ Time Frame: 0-360 minutes ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 7
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • 18F-AV-45
  • Amyvid
  • Florbetapir F 18

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01660815

Locations
Japan
Research Site
Kobe, Japan
Sponsors and Collaborators
Avid Radiopharmaceuticals
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01660815     History of Changes
Other Study ID Numbers: 18F-AV-45-J02, I6E-AV-AVBA
Study First Received: August 7, 2012
Results First Received: July 16, 2013
Last Updated: July 16, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014