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

Phase 1CompletedNCT01564706

Avid Radiopharmaceuticals9 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

florbetapir F 18DRUG

IV injection, 370MBq (10mCi), single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Jenkintown, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 0-380 min after injection

Data from ClinicalTrials.gov

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