Healthy VolunteersEarly Phase 1NCT03082768
Phase 0 Study of [18F]MNI-968 as a Marker for D1 Receptor in Healthy Subjects
A Early Phase 1 study testing [18F]MNI-968 in people with Healthy Volunteers, run by Molecular NeuroImaging at 1 site in United States.
Trial summary
The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [18F]MNI-968
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 1 Mar 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are males or females > 18 years of age and < 50 years of age;
- Are in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Are able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
- Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, they must commit to use a barrier contraception method for the duration of the study.
- Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for the male subjects for the study duration.
- Male subjects must not donate sperm for the study duration.
- Provide informed consent for study procedures.
Who cannot join
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed (i.e. an incidental and limited need), acetaminophen is acceptable, but must be documented as a concomitant medication / significant non-drug therapy.
- Subject has received an investigational therapeutic drug or device within 30 days of screening
- Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines
- Have a history of blood donation in excess of 500 mL of blood within 30 days prior to screening.
- Have a history or presence of any significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, are capable of altering the absorption, metabolism, or elimination of drugs or posing a health risk to participate in the study.
- Have clinically significant findings on laboratory evaluations.
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- Have clinically significant findings on ECG evaluation based on cardiology review.
- History of immunodeficiency disease, including a positive HIV test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result.
- History of drug or alcohol abuse within the 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- History of tobacco product use within 3 months prior to screening, to be verified by urine cotinine screening.
- Positive pregnancy test result using serum beta-HCG, if female.
- Women who are lactating and breastfeeding.
- Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Molecular NeuroImaging, LLC
New Haven, Connecticut, 06510
About this study
Official title: An Open Label, Brain Positron Emission Tomography, Phase 0 Study of [18F]MNI-968 as a Marker for D1 Receptor in Healthy Subjects
The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical.
Read the detailed description
The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical.
- To measure the dynamic uptake and washout of [18F]MNI-968 in brain using positron emission tomography (PET) in healthy volunteers.
- To measure blood metabolites of [18F]MNI-968 in the healthy volunteers and to perform invasive as well as non-invasive modeling to assess [18F]MNI-968 binding to D1 receptor.
- To acquire safety data following injection of [18F]MNI-968
- Evaluation of [18F]MNI-968 PET reliability (test/retest) of several outcome measures
- Conditions
- Healthy Volunteers
- Being tested
- [18F]MNI-968
- Keywords
- HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]MNI-968Drug
Also called PF-06730110
Healthy volunteers recruited for the study will undergo two [18F]MNI-968 injections and PET scans.
| Study group | Role | What they receive |
|---|---|---|
| [18F]MNI-968 | Experimental | To evaluate [18F]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical Receives: Drug: [18F]MNI-968 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-968 binding/uptake and expressed in SUV by using established methods for normalization for 7 HV subjects.
Dynamic uptake and washout of [18F]MNI-968 in brain using positron emission tomography (PET) in healthy volunteers.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start3 Mar 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular NeuroImaging
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Madonia, PA-C, Principal investigator, Molecular NeuroImaging, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082768
- Sponsor's protocol ID
- [18F]MNI-968
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Brain Positron Emission Tomography, Phase 0 Study of [18F]MNI-968 as a Marker for D1 Receptor in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03082768
- Acronym / sponsor ID
- [18F]MNI-968
- Conditions
- Healthy Volunteers
- Keywords
- HV
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Molecular NeuroImagingUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical.
Detailed description
The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical.
- To measure the dynamic uptake and washout of [18F]MNI-968 in brain using positron emission tomography (PET) in healthy volunteers.
- To measure blood metabolites of [18F]MNI-968 in the healthy volunteers and to perform invasive as well as non-invasive modeling to assess [18F]MNI-968 binding to D1 receptor.
- To acquire safety data following injection of [18F]MNI-968
- Evaluation of [18F]MNI-968 PET reliability (test/retest) of several outcome measures
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]MNI-968 | Experimental | Drug: [18F]MNI-968To evaluate [18F]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Are males or females > 18 years of age and < 50 years of age;
- Are in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Are able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
- Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, they must commit to use a barrier contraception method for the duration of the study.
- Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for the male subjects for the study duration.
Key exclusion criteria (14 listed)
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed (i.e. an incidental and limited need), acetaminophen is acceptable, but must be documented as a concomitant medication / significant non-drug therapy.
- Subject has received an investigational therapeutic drug or device within 30 days of screening
- Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines
- Have a history of blood donation in excess of 500 mL of blood within 30 days prior to screening.
- Have a history or presence of any significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, are capable of altering the absorption, metabolism, or elimination of drugs or posing a health risk to participate in the study.
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 |
|---|---|---|
| [18F]MNI-968Also: PF-06730110Healthy volunteers recruited for the study will undergo two [18F]MNI-968 injections and PET scans. | Drug | [18F]MNI-968 |
Primary outcome
Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-968 binding/uptake and expressed in SUV by using established methods for normalization for 7 HV subjects.
Time frame: 1 year
Dynamic uptake and washout of [18F]MNI-968 in brain using positron emission tomography (PET) in healthy volunteers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Related InfoLink provided by the sponsor.
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Screening Protocol
Pain
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.
Jennifer Madonia, PA-C principal investigator
Molecular NeuroImaging, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]MNI-968 in people with Healthy Volunteers, run by Molecular NeuroImaging at 1 site in United States.
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 7 inclusion and 14 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 6 Mar 2018. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-968 binding/uptake and expressed in SUV by using established methods for normalization for 7 HV subjects. (time frame: 1 year). 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 6 Mar 2018.