Alzheimer's DiseasePhase 1NCT01660815
A Study of Florbetapir (18F) in Japanese Healthy Volunteers
A Phase 1 study testing florbetapir (18F) in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 1 site in Japan.
Trial summary
This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed throughout the body of Japanese subjects. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- florbetapir (18F)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2012to Jan 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Have a history of epilepsy or convulsions, except for febrile convulsions during childhood;
- Have clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2;
- Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session;
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum β-HCG at the time of screening) or breastfeeding at screening. Females must agree to avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable methods of contraception such as prescribed birth control or IUD for 24 hours following administration of florbetapir (18F);
- Have a history of severe drug allergy or hypersensitivity;
- Received an investigational medication within the last 30 days or who have participated in a clinical trial with any experimental medication in the last 30 days.
- Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication;
- Have known hypersensitivity to alcohol; and
- In the opinion of the investigator, are otherwise unsuitable for a study of this type.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET Whole Body Biodistribution Using Florbetapir (18F)
This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed throughout the body of Japanese subjects.
- Conditions
- Alzheimer's Disease
- Being tested
- florbetapir (18F)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
florbetapir (18F)Drug
Also called 18F-AV-45, Amyvid, Florbetapir F 18
IV injection, 370 MBq (10mCi), single dose
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Cognitively normal, healthy volunteers at least 45 years of age. Receives: Drug: florbetapir (18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660815
- Sponsor's protocol ID
- 18F-AV-45-J02
- Other IDs
- I6E-AV-AVBA
- Status last verified
- Jul 2013
- First submitted
- 7 Aug 2012
- Last updated
- 19 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Whole Body Biodistribution Using Florbetapir (18F)
- ClinicalTrials.gov ID
- NCT01660815
- Acronym / sponsor ID
- 18F-AV-45-J02
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Posted 19 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed throughout the body of Japanese subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: florbetapir (18F)Cognitively normal, healthy volunteers at least 45 years of age. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (24 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| florbetapir (18F)Also: 18F-AV-45, Amyvid, Florbetapir F 18IV injection, 370 MBq (10mCi), single dose | Drug | Healthy Volunteers |
Primary outcome
Whole Body Radiation Dosimetry
Time frame: 0-360 minutes
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Avid Radiopharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing florbetapir (18F) in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole Body Radiation Dosimetry (time frame: 0-360 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2013.