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

Alzheimer Disease Clinical Trial

Official title:

Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564706
• Other study ID #: 18F-AV-45-A02
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2012
• Last updated: May 11, 2012
• Start date: October 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2012
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Able to lie still on the imaging table for periods up to 1 hour

Exclusion Criteria:

• Radiation exposure for experimental purposes within the last year

• Claustrophobic or otherwise unable to tolerate the imaging procedure

• Medical condition or surgical history that would confound evaluation

• Current clinically significant cardiovascular disease

• Received an investigational medication within the last 30 days

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
United States	Research Site	Jenkintown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Body Radiation Dosimetry	Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.	0-380 min after injection	Yes