A Study of 18F-AV-45 in Healthy Volunteers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Avid Radiopharmaceuticals

ClinicalTrials.gov Identifier:

NCT01564706

First received: March 25, 2012

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

Results First Received: April 3, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Alzheimer Disease
Intervention:	Drug: florbetapir F 18

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Healthy Volunteers	Single i.v. administration of approximately 10mCi 18F-AV-45

Baseline Measures

	Healthy Volunteers
Number of Participants [units: participants]	9
Age [units: years] Mean ± Standard Deviation	57.9 ± 10.31
Gender [units: participants]
Female	6
Male	3
Race/Ethnicity, Customized [units: participants]
Black	1
Caucasian	8
Region of Enrollment [units: participants]
United States	9

Outcome Measures

1. Primary:

Whole Body Radiation Dosimetry [ Time Frame: 0-380 min after injection ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

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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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals
phone: 215-298-0700
e-mail: clinicaloperations@avidrp.com

No publications provided

Responsible Party:	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT01564706 History of Changes
Other Study ID Numbers:	18F-AV-45-A02
Study First Received:	March 25, 2012
Results First Received:	April 3, 2012
Last Updated:	May 11, 2012
Health Authority:	United States: Food and Drug Administration

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