Healthy VolunteerPhase 1NCT05009199
Occupancy of Adenosine A2A Receptors Using the PET Radiotracer [18F]MNI-444
A Phase 1 study testing [18F]MNI-444 in people with Healthy Volunteer, run by Invicro at 1 site in United States.
Trial summary
The overall goal of this protocol is to evaluate the binding of caffeine to adenosine A2A receptors in the brain of participants at risk for developing PD. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- [18F]MNI-444
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to 12 May 2022
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are eligible for inclusion in this study only if they meet all of the following criteria:
- Participant is able to provide written informed consent, which must be obtained before any assessment is performed.
- Female participants must not be of childbearing potential, or if they are of childbearing potential, must agree to use contraception and not donate eggs. At the discretion of the Investigator, participants without documentation of non-childbearing potential may receive pregnancy testing.
- A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (ie, removal of ovaries, fallopian tubes, and/or uterus, tubal ligation) or another cause as determined by the Investigator (eg, Müllerian agenesis).
- Women of childbearing potential must commit to remain abstinent (refrain from heterosexual intercourse) or use 2 forms of birth control, 1 of which is a barrier contraception method, for the duration of the study and 30 days after study completion. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
- Women of childbearing potential must commit to not donate ovum for the duration of the study and 30 days after study completion.
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- Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, 1 of which is a barrier method for male participants for the study duration and 90 days after study completion.
- Male participants must not donate sperm for the study duration and for 90 days after study completion.
- Willing and able to cooperate with study procedures.
- Males and females aged ≥ 30 years.
- Healthy with no clinically relevant finding on physical examination at Screening.
- No personal history of clinically significant neurologic and/or psychiatric disorders, including PD.
- No history of dopamine transporter deficit on DaTscan for any previously acquired DaTscan.
- No cognitive impairment as judged by the Investigator.
- Has a sequence variation in the LRKK2 gene that is a genetic risk factor for the development of PD (based on previous genetic testing in medical history).
Who cannot join
- Participants fulfilling any of the following criteria are not eligible for inclusion in this study:
- Current or prior history of any alcohol or drug abuse in the past 2 years.
- Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
- Participant has received an investigational drug within 30 days or five half-lives prior to the baseline assessments, whichever is longer.
- Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit established by the US Federal Guidelines (effective dose of 50 mSv, including the procedures in this clinical protocol).
- Pregnant, lactating or breastfeeding.
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- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Unsuitable veins for repeated venipuncture.
- Brain MRI with clinically significant structural abnormalities.
- Has a medical condition or takes a medication likely to interfere with assessment of brain A2A receptor levels by PET in the opinion of the Investigator.
- 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, unless a previous MRI is used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Proof of Principle Study to Evaluate the Occupancy of A2A Receptors Using PET Radiotracer [18F]MNI-444 & Repeated Dosing of Oral Caffeine in Participants Without Parkinson's Disease Who Carry Pathogenic Mutation in the LRRK2 Gene
The overall goal of this protocol is to evaluate the binding of caffeine to adenosine A2A receptors in the brain of participants at risk for developing PD.
Read the detailed description
The overall goal of this protocol is to evaluate the binding of caffeine to adenosine A2A receptors in the brain of participants at risk for developing PD. The specific objectives are:
- To evaluate the pharmacokinetics (PK) and pharmacodynamics of multiple doses of oral caffeine on striatal binding of the adenosine A2A receptor ligand [18F]MNI-444.
- To evaluate the safety and tolerability of 3 doses of the positron emission tomography (PET) radiotracer, [18F]MNI-444.
- To evaluate the safety and tolerability of multiple doses of oral caffeine in this paradigm.
- Conditions
- Healthy Volunteer
- Being tested
- [18F]MNI-444
- Keywords
- HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]MNI-444Drug
Subjects will undergo PET imaging using [18F]MNI-444.
| Study group | Role | What they receive |
|---|---|---|
| [18F]MNI-444 | Experimental | After a wash-out of caffeine of at least 24 hours, each participant will receive a single injection of [18F]MNI-444 followed by brain PET imaging of up to 90 minutes to establish baseline A2A receptor binding. Receives: Drug: [18F]MNI-444 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacodynamics of multiple doses of oral caffeine on striatal binding of the adenosine A2A receptor ligand [18F]MNI-444.
A2A receptor occupancy will be assessed by comparing the binding potential (BPND) of [18F]MNI-444 in striatal regions of interest (ROIs) for each post-dose scan (ie, peak and trough scans assessed separately) with the baseline scan in the same participant.
Measured: 1 year
To evaluate the pharmacokinetics of multiple doses of oral caffeine on striatal binding of the adenosine A2A receptor ligand [18F]MNI-444.
Plasma PK samples for caffeine and metabolite paraxanthine will be collected during [18F]MNI-444 PET imaging sessions. These concentrations will be used to help understand the A2A receptor occupancy values.
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 Aug 2021
- Study start24 Jun 2021
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Russell, M.D., Ph.D, Principal investigator, Invicro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009199
- Sponsor's protocol ID
- [18F]MNI-444 (9564)
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Proof of Principle Study to Evaluate the Occupancy of A2A Receptors Using PET Radiotracer [18F]MNI-444 & Repeated Dosing of Oral Caffeine in Participants Without Parkinson's Disease Who Carry Pathogenic Mutation in the LRRK2 Gene
- ClinicalTrials.gov ID
- NCT05009199
- Acronym / sponsor ID
- [18F]MNI-444 (9564)
- Conditions
- Healthy Volunteer
- Keywords
- HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- InvicroUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 17 Aug 2021 (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 binding of caffeine to adenosine A2A receptors in the brain of participants at risk for developing PD.
Detailed description
The overall goal of this protocol is to evaluate the binding of caffeine to adenosine A2A receptors in the brain of participants at risk for developing PD. The specific objectives are:
- To evaluate the pharmacokinetics (PK) and pharmacodynamics of multiple doses of oral caffeine on striatal binding of the adenosine A2A receptor ligand [18F]MNI-444.
- To evaluate the safety and tolerability of 3 doses of the positron emission tomography (PET) radiotracer, [18F]MNI-444.
- To evaluate the safety and tolerability of multiple doses of oral caffeine in this paradigm.
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-444 | Experimental | Drug: [18F]MNI-444After a wash-out of caffeine of at least 24 hours, each participant will receive a single injection of [18F]MNI-444 followed by brain PET imaging of up to 90 minutes to establish baseline A2A receptor binding. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participants are eligible for inclusion in this study only if they meet all of the following criteria:
- Participant is able to provide written informed consent, which must be obtained before any assessment is performed.
- Female participants must not be of childbearing potential, or if they are of childbearing potential, must agree to use contraception and not donate eggs. At the discretion of the Investigator, participants without documentation of non-childbearing potential may receive pregnancy testing.
- Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, 1 of which is a barrier method for male participants for the study duration and 90 days after study completion.
- Male participants must not donate sperm for the study duration and for 90 days after study completion.
Key exclusion criteria (11 listed)
- Participants fulfilling any of the following criteria are not eligible for inclusion in this study:
- Current or prior history of any alcohol or drug abuse in the past 2 years.
- Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
- Participant has received an investigational drug within 30 days or five half-lives prior to the baseline assessments, whichever is longer.
- Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit established by the US Federal Guidelines (effective dose of 50 mSv, including the procedures in this clinical protocol).
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-444Subjects will undergo PET imaging using [18F]MNI-444. | Drug | [18F]MNI-444 |
Primary outcome
To evaluate the pharmacodynamics of multiple doses of oral caffeine on striatal binding of the adenosine A2A receptor ligand [18F]MNI-444.
Time frame: 1 year
A2A receptor occupancy will be assessed by comparing the binding potential (BPND) of [18F]MNI-444 in striatal regions of interest (ROIs) for each post-dose scan (ie, peak and trough scans assessed separately) with the baseline scan in the same participant.
To evaluate the pharmacokinetics of multiple doses of oral caffeine on striatal binding of the adenosine A2A receptor ligand [18F]MNI-444.
Time frame: 1 year
Plasma PK samples for caffeine and metabolite paraxanthine will be collected during [18F]MNI-444 PET imaging sessions. These concentrations will be used to help understand the A2A receptor occupancy values.
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 5 Jul 2022.
- Related InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
David Russell, M.D., Ph.D principal investigator
Invicro
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-444 in people with Healthy Volunteer, run by Invicro 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 15 inclusion and 11 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 5 Jul 2022. 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?
To evaluate the pharmacodynamics of multiple doses of oral caffeine on striatal binding of the adenosine A2A receptor ligand [18F]MNI-444. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 5 Jul 2022.