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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01660815
First Posted: August 9, 2012
Last Update Posted: September 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
Results First Submitted: July 16, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Alzheimer's Disease
Intervention: Drug: florbetapir (18F)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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