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

• ClinicalTrials.gov Identifier: NCT01660815
• Recruitment Status: Completed
• First Posted: August 9, 2012
• Results First Posted: September 19, 2013
• Last Update Posted: September 19, 2013
• Sponsor: Avid Radiopharmaceuticals
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): Avid Radiopharmaceuticals

Tracking Information

• First Submitted Date: August 7, 2012
• First Posted Date: August 9, 2012
• Results First Submitted Date: July 16, 2013
• Results First Posted Date: September 19, 2013
• Last Update Posted Date: September 19, 2013
• Study Start Date: August 2012
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Florbetapir (18F) in Japanese Healthy Volunteers
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Alzheimer's Disease

Intervention

Drug: florbetapir (18F)

IV injection, 370 MBq (10mCi), single dose

Other Names:

• 18F-AV-45
• Amyvid
• Florbetapir F 18

Study Arms

Experimental: Healthy Volunteers

Cognitively normal, healthy volunteers at least 45 years of age.

Intervention: Drug: florbetapir (18F)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2013): 7
• Original Estimated Enrollment (submitted: August 8, 2012): 6
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01660815
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Avid Radiopharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Avid Radiopharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Eli Lilly and Company

Investigators

• Study Director: Chief Medical Officer; Avid Radiopharmaceuticals

• PRS Account: Avid Radiopharmaceuticals
• Verification Date: July 2013