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

NCT01660815 | Completed Phase 1 Results

• 2 other identifiers: 18F-AV-45-J02I6E-AV-AVBA
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Whole Body Radiation Dosimetry

  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.

  0-360 minutes

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

Cognitively normal, healthy volunteers at least 45 years of age.

Drug: florbetapir (18F)

Interventions

florbetapir (18F) DRUG

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

Also known as: 18F-AV-45, Amyvid, Florbetapir F 18

Healthy Volunteers

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are Japanese cognitively normal healthy males or females at least 45 years of age;
• Give informed consent; and
• Are able to lie still on the imaging table for periods up to one hour.

You may not qualify if:

• Have had radiation exposure (PET, SPECT or CT scans) for experimental purposes within the last year;
• Are claustrophobic or otherwise unable to tolerate the imaging procedure;
• Have medical conditions or surgical history that would confound evaluation of dosimetry (e.g., liver disease, colectomy etc.);
• Have current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:
• cardiac surgery or myocardial infarction within the last 6 months;
• unstable angina;
• coronary artery disease that required a change in medication within the last 3 months;
• decompensated congestive heart failure;
• significant cardiac arrhythmia or conduction disturbance, particularly those resulting in atrial or ventricular fibrillation, or causing syncope, near syncope, or other alterations in mental status;
• severe mitral or aortic valvular disease;
• uncontrolled high blood pressure;
• congenital heart disease;
• clinically significant abnormal result on ECG, including but not limited to QTc\>450 msec; Before enrolling a patient with any evidence of the above conditions, the investigator must contact the sponsor;
• Have current clinically significant medical comorbidities, as indicated by history, physical exam, or laboratory evaluations that might pose a potential safety risk, interfere with the absorption or metabolism of the study medication or limit interpretation of the trial results. These include but are not limited to clinically significant hepatic, renal, pulmonary, metabolic or endocrine disease, cancer;
• Have a history of drug or alcohol abuse within the last year, or prior prolonged history of abuse;

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Research Site

Kobe, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avid Radiopharmaceuticals, Inc.

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 9, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 19, 2013
• Results First Posted: September 19, 2013

Record last verified: 2013-07

Locations

JP (1)