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

PET Whole Body Biodistribution Using Florbetapir (18F)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01660815
Enrollment
7
Registered
2012-08-09
Start date
2012-08-31
Completion date
2013-01-31
Last updated
2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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

Interventions

DRUGflorbetapir (18F)

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

Sponsors

Eli Lilly and Company
CollaboratorINDUSTRY
Avid Radiopharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Whole Body Radiation Dosimetry0-360 minutesRadiation 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.

Countries

Japan

Participant flow

Participants by arm

ArmCount
Healthy Volunteers
Cognitively normal, healthy volunteers at least 45 years of age. florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose
7
Total7

Baseline characteristics

CharacteristicHealthy Volunteers
Age Continuous54.4 years
STANDARD_DEVIATION 5.71
Region of Enrollment
Japan
7 participants
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
1 / 7
serious
Total, serious adverse events
0 / 7

Outcome results

Primary

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.

Time frame: 0-360 minutes

Population: Analysis population includes the 6 subjects who completed the study and had valid imaging data for quantitative analysis.

ArmMeasureGroupValue (MEAN)Dispersion
50-kg ModelWhole Body Radiation DosimetryKidneys0.0237 mSv/MBqStandard Deviation 0.00393
50-kg ModelWhole Body Radiation DosimetryPancreas0.0205 mSv/MBqStandard Deviation 0.00188
50-kg ModelWhole Body Radiation DosimetryBreasts0.0108 mSv/MBqStandard Deviation 0.00123
50-kg ModelWhole Body Radiation DosimetryRed marrow0.0221 mSv/MBqStandard Deviation 0.00182
50-kg ModelWhole Body Radiation DosimetryLower large intestine wall0.0210 mSv/MBqStandard Deviation 0.00245
50-kg ModelWhole Body Radiation DosimetrySkin0.00993 mSv/MBqStandard Deviation 0.00113
50-kg ModelWhole Body Radiation DosimetryThymus0.0133 mSv/MBqStandard Deviation 0.00176
50-kg ModelWhole Body Radiation DosimetrySmall intestine0.0364 mSv/MBqStandard Deviation 0.00668
50-kg ModelWhole Body Radiation DosimetryLiver0.0456 mSv/MBqStandard Deviation 0.0249
50-kg ModelWhole Body Radiation DosimetrySpleen0.0151 mSv/MBqStandard Deviation 0.00134
50-kg ModelWhole Body Radiation DosimetryGallbladder wall0.310 mSv/MBqStandard Deviation 0.192
50-kg ModelWhole Body Radiation DosimetryStomach wall0.0165 mSv/MBqStandard Deviation 0.000991
50-kg ModelWhole Body Radiation DosimetryLungs0.0127 mSv/MBqStandard Deviation 0.000885
50-kg ModelWhole Body Radiation DosimetryTestes0.0128 mSv/MBqStandard Deviation 0.00118
50-kg ModelWhole Body Radiation DosimetryThyroid0.0130 mSv/MBqStandard Deviation 0.00203
50-kg ModelWhole Body Radiation DosimetryBrain0.0179 mSv/MBqStandard Deviation 0.00234
50-kg ModelWhole Body Radiation DosimetryTotal body0.0161 mSv/MBqStandard Deviation 0.000468
50-kg ModelWhole Body Radiation DosimetryMuscle0.0136 mSv/MBqStandard Deviation 0.000989
50-kg ModelWhole Body Radiation DosimetryUpper large intestine wall0.0397 mSv/MBqStandard Deviation 0.00805
50-kg ModelWhole Body Radiation DosimetryHeart wall0.0247 mSv/MBqStandard Deviation 0.00453
50-kg ModelWhole Body Radiation DosimetryUrinary bladder wall0.0578 mSv/MBqStandard Deviation 0.0364
50-kg ModelWhole Body Radiation DosimetryOsteogenic cells0.0493 mSv/MBqStandard Deviation 0.00575
50-kg ModelWhole Body Radiation DosimetryUterus0.0199 mSv/MBqStandard Deviation 0.00157
50-kg ModelWhole Body Radiation DosimetryAdrenals0.0186 mSv/MBqStandard Deviation 0.00099
50-kg ModelWhole Body Radiation DosimetryEffective dose0.0207 mSv/MBqStandard Deviation 0.00266
50-kg ModelWhole Body Radiation DosimetryOvaries0.0194 mSv/MBqStandard Deviation 0.00088
70-kg ModelWhole Body Radiation DosimetryEffective dose0.0149 mSv/MBqStandard Deviation 0.00198
70-kg ModelWhole Body Radiation DosimetryThymus0.00931 mSv/MBqStandard Deviation 0.00125
70-kg ModelWhole Body Radiation DosimetryAdrenals0.0132 mSv/MBqStandard Deviation 0.000685
70-kg ModelWhole Body Radiation DosimetryBrain0.0157 mSv/MBqStandard Deviation 0.00207
70-kg ModelWhole Body Radiation DosimetryBreasts0.00759 mSv/MBqStandard Deviation 0.000843
70-kg ModelWhole Body Radiation DosimetryGallbladder wall0.268 mSv/MBqStandard Deviation 0.167
70-kg ModelWhole Body Radiation DosimetryHeart wall0.0171 mSv/MBqStandard Deviation 0.00316
70-kg ModelWhole Body Radiation DosimetryKidneys0.0177 mSv/MBqStandard Deviation 0.00291
70-kg ModelWhole Body Radiation DosimetryLower large intestine wall0.0161 mSv/MBqStandard Deviation 0.00178
70-kg ModelWhole Body Radiation DosimetryLiver0.0313 mSv/MBqStandard Deviation 0.0169
70-kg ModelWhole Body Radiation DosimetryLungs0.00844 mSv/MBqStandard Deviation 0.000516
70-kg ModelWhole Body Radiation DosimetryMuscle0.00987 mSv/MBqStandard Deviation 0.000723
70-kg ModelWhole Body Radiation DosimetryOsteogenic cells0.0327 mSv/MBqStandard Deviation 0.00377
70-kg ModelWhole Body Radiation DosimetryOvaries0.0139 mSv/MBqStandard Deviation 0.000727
70-kg ModelWhole Body Radiation DosimetryPancreas0.0150 mSv/MBqStandard Deviation 0.00151
70-kg ModelWhole Body Radiation DosimetryRed marrow0.0155 mSv/MBqStandard Deviation 0.00118
70-kg ModelWhole Body Radiation DosimetrySkin0.00730 mSv/MBqStandard Deviation 0.000823
70-kg ModelWhole Body Radiation DosimetrySmall intestine0.0269 mSv/MBqStandard Deviation 0.00506
70-kg ModelWhole Body Radiation DosimetrySpleen0.0105 mSv/MBqStandard Deviation 0.00105
70-kg ModelWhole Body Radiation DosimetryStomach wall0.0120 mSv/MBqStandard Deviation 0.000689
70-kg ModelWhole Body Radiation DosimetryThyroid0.00922 mSv/MBqStandard Deviation 0.00143
70-kg ModelWhole Body Radiation DosimetryTotal body0.0117 mSv/MBqStandard Deviation 0.00032
70-kg ModelWhole Body Radiation DosimetryUpper large intestine wall0.0299 mSv/MBqStandard Deviation 0.00611
70-kg ModelWhole Body Radiation DosimetryUrinary bladder wall0.0442 mSv/MBqStandard Deviation 0.0276
70-kg ModelWhole Body Radiation DosimetryUterus0.0146 mSv/MBqStandard Deviation 0.00123
70-kg ModelWhole Body Radiation DosimetryTestes0.00913 mSv/MBqStandard Deviation 0.00091

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026