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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
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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


  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
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals, Inc.
phone: 215-298-0700
e-mail: clinicaloperations@avidrp.com


No publications provided


Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01660815     History of Changes
Other Study ID Numbers: 18F-AV-45-J02, I6E-AV-AVBA
Study First Received: August 7, 2012
Results First Received: July 16, 2013
Last Updated: July 16, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency