Trial Outcomes & Findings for A Study of Florbetapir (18F) in Japanese Healthy Volunteers (NCT NCT01660815)

Last Updated: 2013-09-19

Results Overview

Radiation dose values (millisieverts/megabecquerel \[mSv/MBq\]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

0-360 minutes

Results posted on

2013-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Volunteers Cognitively normal, healthy volunteers at least 45 years of age. florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers n=7 Participants Cognitively normal, healthy volunteers at least 45 years of age. florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose
Age Continuous	54.4 years STANDARD_DEVIATION 5.71 • n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Region of Enrollment Japan	7 participants n=93 Participants

PRIMARY outcome

Timeframe: 0-360 minutes

Population: Analysis population includes the 6 subjects who completed the study and had valid imaging data for quantitative analysis.

Outcome measures

Outcome measures
Measure	50-kg Model n=6 Participants Radiation dose estimate using a 50-kg model.	70-kg Model n=6 Participants Radiation dose estimate using a 70-kg model.
Whole Body Radiation Dosimetry Heart wall	0.0247 mSv/MBq Standard Deviation 0.00453	0.0171 mSv/MBq Standard Deviation 0.00316
Whole Body Radiation Dosimetry Adrenals	0.0186 mSv/MBq Standard Deviation 0.000990	0.0132 mSv/MBq Standard Deviation 0.000685
Whole Body Radiation Dosimetry Brain	0.0179 mSv/MBq Standard Deviation 0.00234	0.0157 mSv/MBq Standard Deviation 0.00207
Whole Body Radiation Dosimetry Breasts	0.0108 mSv/MBq Standard Deviation 0.00123	0.00759 mSv/MBq Standard Deviation 0.000843
Whole Body Radiation Dosimetry Gallbladder wall	0.310 mSv/MBq Standard Deviation 0.192	0.268 mSv/MBq Standard Deviation 0.167
Whole Body Radiation Dosimetry Kidneys	0.0237 mSv/MBq Standard Deviation 0.00393	0.0177 mSv/MBq Standard Deviation 0.00291
Whole Body Radiation Dosimetry Lower large intestine wall	0.0210 mSv/MBq Standard Deviation 0.00245	0.0161 mSv/MBq Standard Deviation 0.00178
Whole Body Radiation Dosimetry Liver	0.0456 mSv/MBq Standard Deviation 0.0249	0.0313 mSv/MBq Standard Deviation 0.0169
Whole Body Radiation Dosimetry Lungs	0.0127 mSv/MBq Standard Deviation 0.000885	0.00844 mSv/MBq Standard Deviation 0.000516
Whole Body Radiation Dosimetry Muscle	0.0136 mSv/MBq Standard Deviation 0.000989	0.00987 mSv/MBq Standard Deviation 0.000723
Whole Body Radiation Dosimetry Osteogenic cells	0.0493 mSv/MBq Standard Deviation 0.00575	0.0327 mSv/MBq Standard Deviation 0.00377
Whole Body Radiation Dosimetry Ovaries	0.0194 mSv/MBq Standard Deviation 0.000880	0.0139 mSv/MBq Standard Deviation 0.000727
Whole Body Radiation Dosimetry Pancreas	0.0205 mSv/MBq Standard Deviation 0.00188	0.0150 mSv/MBq Standard Deviation 0.00151
Whole Body Radiation Dosimetry Red marrow	0.0221 mSv/MBq Standard Deviation 0.00182	0.0155 mSv/MBq Standard Deviation 0.00118
Whole Body Radiation Dosimetry Skin	0.00993 mSv/MBq Standard Deviation 0.00113	0.00730 mSv/MBq Standard Deviation 0.000823
Whole Body Radiation Dosimetry Small intestine	0.0364 mSv/MBq Standard Deviation 0.00668	0.0269 mSv/MBq Standard Deviation 0.00506
Whole Body Radiation Dosimetry Spleen	0.0151 mSv/MBq Standard Deviation 0.00134	0.0105 mSv/MBq Standard Deviation 0.00105
Whole Body Radiation Dosimetry Stomach wall	0.0165 mSv/MBq Standard Deviation 0.000991	0.0120 mSv/MBq Standard Deviation 0.000689
Whole Body Radiation Dosimetry Testes	0.0128 mSv/MBq Standard Deviation 0.00118	0.00913 mSv/MBq Standard Deviation 0.000910
Whole Body Radiation Dosimetry Thymus	0.0133 mSv/MBq Standard Deviation 0.00176	0.00931 mSv/MBq Standard Deviation 0.00125
Whole Body Radiation Dosimetry Thyroid	0.0130 mSv/MBq Standard Deviation 0.00203	0.00922 mSv/MBq Standard Deviation 0.00143
Whole Body Radiation Dosimetry Total body	0.0161 mSv/MBq Standard Deviation 0.000468	0.0117 mSv/MBq Standard Deviation 0.000320
Whole Body Radiation Dosimetry Upper large intestine wall	0.0397 mSv/MBq Standard Deviation 0.00805	0.0299 mSv/MBq Standard Deviation 0.00611
Whole Body Radiation Dosimetry Urinary bladder wall	0.0578 mSv/MBq Standard Deviation 0.0364	0.0442 mSv/MBq Standard Deviation 0.0276
Whole Body Radiation Dosimetry Uterus	0.0199 mSv/MBq Standard Deviation 0.00157	0.0146 mSv/MBq Standard Deviation 0.00123
Whole Body Radiation Dosimetry Effective dose	0.0207 mSv/MBq Standard Deviation 0.00266	0.0149 mSv/MBq Standard Deviation 0.00198

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy Volunteers n=7 participants at risk Cognitively normal, healthy volunteers at least 45 years of age. florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Number of events 1

Additional Information

Chief Medical Officer

Avid Radiopharmaceuticals, Inc.

Phone: 215-298-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60