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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
Results First Received: July 16, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Alzheimer's Disease
Intervention: Drug: florbetapir (18F)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Healthy Volunteers

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

florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose


Participant Flow:   Overall Study
    Healthy Volunteers  
STARTED     7  
COMPLETED     7  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Healthy Volunteers

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

florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose


Baseline Measures
    Healthy Volunteers  
Number of Participants  
[units: participants]
  7  
Age  
[units: years]
Mean ± Standard Deviation
  54.4  ± 5.71  
Gender  
[units: participants]
 
Female     1  
Male     6  
Region of Enrollment  
[units: participants]
 
Japan     7  



  Outcome Measures

1.  Primary:   Whole Body Radiation Dosimetry   [ Time Frame: 0-360 minutes ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Healthy Volunteers

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

florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose


Other Adverse Events
    Healthy Volunteers  
Total, other (not including serious) adverse events    
# participants affected / at risk     1/7  
Musculoskeletal and connective tissue disorders    
Back pain * 1  
# participants affected / at risk     1/7 (14.29%)  
# events     1  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 15.0



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information