Healthy VolunteersPhase 1NCT03142724
Assessment of the Biodistribution and Safety of [18F]MNI-968 in Healthy Subjects
A 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 the biodistribution of [18F]MNI-968 as a D1 receptor targeted radiopharmaceutical. Read more about this study
- Who is it for?
- Ages 18 to 55 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
- 1 May 2017to 1 Mar 2018
- Phase
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant is 18 to 55 years old.
- Written informed consent must be obtained before any assessment is performed.
- 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, 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 male subjects for the study duration.
- Male subjects must not donate sperm for the study duration.
- Willing and able to cooperate with study procedures
Who cannot join
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- The subject is a currently exposed to nicotine products or had regular nicotine exposure within a six month period, to be verified by urine cotinine screening.
- History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening visit.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
- 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 does not exceed the effective dose of 50 mSv, equivalent with the acceptable annual limits established by the US Federal Guidelines.
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- Pregnancy or women who are breastfeeding, lactating or nursing.
- Unsuitable veins for repeated venipuncture.
- History of immunodeficiency diseases, including a positive HIV test result
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result.
Trial locations and contacts
1 site in 1 country.
United States1 site
Molecular NeuroImaging, LLC
New Haven, Connecticut, 06510
About this study
Official title: Assessment of the Biodistribution and Safety of [18F]MNI-968 (Aka PF-06730110) in Healthy Subjects
The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1 receptor targeted radiopharmaceutical.
Read the detailed description
The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1 receptor targeted radiopharmaceutical. The specific objectives are:
- To determine the radiation dosimetry of [18F]MNI-968
- To assess the safety and tolerability of a single dose of [18F]MNI-968
- 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 a single [18F]MNI-968 injections and PET scans.
| Study group | Role | What they receive |
|---|---|---|
| [18F]MNI-968 | Experimental | To assess the safety and tolerability and to determine the radiation dosimetry of [18F]MNI-968. Receives: Drug: [18F]MNI-968 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body tomographic PET images will be obtained for 6 healthy volunteers, and reviewed visually for assessment of body organ distribution of radioactivity.
Volumes of interest (VOI) will be placed on the visually identified source organs, and subsequently used for all the study PET frames. Activity within these volumes of interest is expressed in units of total radioactivity (kBq). Radioactivity will be corrected for body attenuation, but not for decay, and time activity data (TAC) generated for each source organ.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 May 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
- 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
- NCT03142724
- Sponsor's protocol ID
- [18F]MNI-968 Dosimetry
- Status last verified
- Mar 2018
- First submitted
- 2 May 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
- Assessment of the Biodistribution and Safety of [18F]MNI-968 (Aka PF-06730110) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03142724
- Acronym / sponsor ID
- [18F]MNI-968 Dosimetry
- Conditions
- Healthy Volunteers
- Keywords
- HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Molecular NeuroImagingUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 5 May 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 the biodistribution of [18F]MNI-968 as a D1 receptor targeted radiopharmaceutical.
Detailed description
The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1 receptor targeted radiopharmaceutical. The specific objectives are:
- To determine the radiation dosimetry of [18F]MNI-968
- To assess the safety and tolerability of a single dose of [18F]MNI-968
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 assess the safety and tolerability and to determine the radiation dosimetry of [18F]MNI-968. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The participant is 18 to 55 years old.
- Written informed consent must be obtained before any assessment is performed.
- 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, 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 male subjects for the study duration.
- Male subjects must not donate sperm for the study duration.
Key exclusion criteria (10 listed)
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- The subject is a currently exposed to nicotine products or had regular nicotine exposure within a six month period, to be verified by urine cotinine screening.
- History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening visit.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
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 a single [18F]MNI-968 injections and PET scans. | Drug | [18F]MNI-968 |
Primary outcome
Whole body tomographic PET images will be obtained for 6 healthy volunteers, and reviewed visually for assessment of body organ distribution of radioactivity.
Time frame: 2 Months
Volumes of interest (VOI) will be placed on the visually identified source organs, and subsequently used for all the study PET frames. Activity within these volumes of interest is expressed in units of total radioactivity (kBq). Radioactivity will be corrected for body attenuation, but not for decay, and time activity data (TAC) generated for each source organ.
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 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 6 inclusion and 10 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?
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?
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?
Whole body tomographic PET images will be obtained for 6 healthy volunteers, and reviewed visually for assessment of body organ distribution of radioactivity. (time frame: 2 Months). 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.