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

Phase 1
Completed
Conditions
Alzheimer Disease
Interventions
Registration Number
NCT01564706
Lead Sponsor
Avid Radiopharmaceuticals
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
9
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Healthy Volunteersflorbetapir F 18Healthy male or female subjects, between 18 and 85 years of age.
Primary Outcome Measures
NameTimeMethod
Whole Body Radiation Dosimetry0-380 min after injection

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Research Site

🇺🇸

Jenkintown, Pennsylvania, United States

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