We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01660815
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : September 19, 2013
Last Update Posted : September 19, 2013
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 7, 2012
First Posted Date  ICMJE August 9, 2012
Results First Submitted Date  ICMJE July 16, 2013
Results First Posted Date  ICMJE September 19, 2013
Last Update Posted Date September 19, 2013
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
Whole Body Radiation Dosimetry [ Time Frame: 0-360 minutes ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2012)
Whole Body Radiation Dosimetry [ Time Frame: 0-360 minutes ]
Radiation dose values (mSv/MBq)will be calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin,spleen, testes, thymus, urinary bladder wall, uterus, and total body.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of Florbetapir (18F) in Japanese Healthy Volunteers
Official Title  ICMJE PET Whole Body Biodistribution Using Florbetapir (18F)
Brief Summary This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed throughout the body of Japanese subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: florbetapir (18F)
IV injection, 370 MBq (10mCi), single dose
Other Names:
  • 18F-AV-45
  • Amyvid
  • Florbetapir F 18
Study Arms  ICMJE Experimental: Healthy Volunteers
Cognitively normal, healthy volunteers at least 45 years of age.
Intervention: Drug: florbetapir (18F)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2012)
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01660815
Other Study ID Numbers  ICMJE 18F-AV-45-J02
I6E-AV-AVBA ( Other Identifier: Eli Lilly Japan )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Avid Radiopharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Avid Radiopharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
PRS Account Avid Radiopharmaceuticals
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP