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

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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:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Type Interventional
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)
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Volunteers
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Cognitively normal, healthy volunteers at least 45 years of age.

florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose
Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Healthy Volunteers
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Cognitively normal, healthy volunteers at least 45 years of age.

florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
54.4  (5.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
1
  14.3%
Male
6
  85.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 7 participants
7
1.Primary Outcome
Title Whole Body Radiation Dosimetry
Hide Description 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
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Hide Analysis Population Description
Analysis population includes the 6 subjects who completed the study and had valid imaging data for quantitative analysis.
Arm/Group Title 50-kg Model 70-kg Model
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Radiation dose estimate using a 50-kg model.
Radiation dose estimate using a 70-kg model.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: mSv/MBq
Adrenals 0.0186  (0.000990) 0.0132  (0.000685)
Brain 0.0179  (0.00234) 0.0157  (0.00207)
Breasts 0.0108  (0.00123) 0.00759  (0.000843)
Gallbladder wall 0.310  (0.192) 0.268  (0.167)
Heart wall 0.0247  (0.00453) 0.0171  (0.00316)
Kidneys 0.0237  (0.00393) 0.0177  (0.00291)
Lower large intestine wall 0.0210  (0.00245) 0.0161  (0.00178)
Liver 0.0456  (0.0249) 0.0313  (0.0169)
Lungs 0.0127  (0.000885) 0.00844  (0.000516)
Muscle 0.0136  (0.000989) 0.00987  (0.000723)
Osteogenic cells 0.0493  (0.00575) 0.0327  (0.00377)
Ovaries 0.0194  (0.000880) 0.0139  (0.000727)
Pancreas 0.0205  (0.00188) 0.0150  (0.00151)
Red marrow 0.0221  (0.00182) 0.0155  (0.00118)
Skin 0.00993  (0.00113) 0.00730  (0.000823)
Small intestine 0.0364  (0.00668) 0.0269  (0.00506)
Spleen 0.0151  (0.00134) 0.0105  (0.00105)
Stomach wall 0.0165  (0.000991) 0.0120  (0.000689)
Testes 0.0128  (0.00118) 0.00913  (0.000910)
Thymus 0.0133  (0.00176) 0.00931  (0.00125)
Thyroid 0.0130  (0.00203) 0.00922  (0.00143)
Total body 0.0161  (0.000468) 0.0117  (0.000320)
Upper large intestine wall 0.0397  (0.00805) 0.0299  (0.00611)
Urinary bladder wall 0.0578  (0.0364) 0.0442  (0.0276)
Uterus 0.0199  (0.00157) 0.0146  (0.00123)
Effective dose 0.0207  (0.00266) 0.0149  (0.00198)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Volunteers
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Cognitively normal, healthy volunteers at least 45 years of age.

florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose
All-Cause Mortality
Healthy Volunteers
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Healthy Volunteers
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Volunteers
Affected / at Risk (%) # Events
Total   1/7 (14.29%)    
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals, Inc.
Phone: 215-298-0700
EMail: clinicaloperations@avidrp.com
Layout table for additonal information
Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01660815    
Other Study ID Numbers: 18F-AV-45-J02
I6E-AV-AVBA ( Other Identifier: Eli Lilly Japan )
First Submitted: August 7, 2012
First Posted: August 9, 2012
Results First Submitted: July 16, 2013
Results First Posted: September 19, 2013
Last Update Posted: September 19, 2013