Healthy Volunteers (HV)Early Phase 1NCT03695926
Assessment of [18F]MNI-1054 as a Marker for LSD1
A Early Phase 1 study testing [18F]MNI-1054 in people with Healthy Volunteers (HV), run by Invicro at 1 site in United States.
Trial summary
The primary objective of this protocol is to evaluate [18F]MNI-1054 as a Lysine-specific histone demethylase 1A (LSD1) enzyme 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 (HV)
- What is being tested?
- [18F]MNI-1054
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2018to 2 May 2019
- 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
- Understand the study procedures and agree to participate by providing written informed consent.
- Are willing and able to comply with all study procedures and restrictions.
- Are males or females > 18 years of age and < 50 years of age.
- Are in good health as determined by the investigator based on clinical evaluations including past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and prior to the first dose of study drug.
- Are a current nonsmoker who has not used tobacco- or nicotine-containing products (eg, nicotine patch) for at least 6 months prior to the first dose of study drug or first invasive procedure.
- Are a female subject of nonchildbearing potential, 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 (i.e. 12 consecutive months with no menses without an alternative medical cause) or, if they are of child-bearing potential, must commit to use two methods of contraception, one of which is a barrier method for the duration of the study.
- Are a male subject who is sterile or agrees to use an appropriate method of contraception, including a condom with or without spermicidal cream or jelly, from the first dose of study drug until 30 days after the last dose of study drug. No restrictions are required for a vasectomized male subject provided the subject is at least 1-year postbilateral vasectomy procedure prior to the first dose of study drug. A male subject whose vasectomy procedure was performed less than 1 year prior to the first dose of study drug must follow the same restrictions as a nonvasectomized man. Appropriate documentation of surgical procedure should be provided.
- Male subjects must not donate sperm for the study duration and for 30 days following the last dose of study drug.
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.
- Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- 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 millisievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines.
- Has a known hypersensitivity to any component of the formulation of [18F]MNI-1054 or related compounds.
- Major surgery, or donation or loss of 400 mL or more of blood within four (4) weeks prior to initial dosing, or longer if required by local regulation.
- 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.
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- The subject has a history of cancer (malignancy).
- Have clinically significant findings on laboratory evaluations.
- Have clinically significant findings on ECG evaluation.
- History of immunodeficiency diseases, 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 (i.e. positive drug or alcohol screen) conducted during the screening.
- The subject has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer [354 mL/12 oz], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).
- The subject consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Positive pregnancy test result using serum beta-human chorionic gonadotropin (HCG), if female.
- Women who are lactating and breastfeeding.
- The subject is an employee of the sponsor or trial site or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor or trial site.
- MRI exclusion criteria include: Findings of infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease.
- 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.
About this study
Official title: An Open-label, Brain Positron Emission Tomography, Phase 0 Study of [18F]MNI-1054 as a Marker for LSD1 in Healthy Subjects
The primary objective of this protocol is to evaluate [18F]MNI-1054 as a Lysine-specific histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical.
Read the detailed description
The primary objective of this protocol is to evaluate [18F]MNI-1054 as a Lysine-specific histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical. The specific objectives are:
- To measure the dynamic uptake and washout of [18F]MNI-1054 in brain using positron emission tomography (PET) in healthy volunteers.
- To measure blood metabolites of [18F]MNI-1054 in the healthy volunteers and to perform invasive as well as non-invasive modeling to assess its ability to measure LSD1 in the brain.
- To acquire safety data following injection of [18F]MNI-1054
- Evaluation of [18F]MNI-1054 PET reliability (test/retest) of the tracer parameters in healthy volunteers.
- Conditions
- Healthy Volunteers (HV)
- Being tested
- [18F]MNI-1054
- Keywords
- HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]MNI-1054Drug
Healthy volunteers recruited for the study will undergo a [18F]MNI-1054 PET scan.
| Study group | Role | What they receive |
|---|---|---|
| [18F]MNI-1054 | Experimental | To measure blood metabolites, dynamic uptake, and washout of [18F]MNI-1054 in brain using positron emission tomography (PET) in healthy volunteers. Receives: Drug: [18F]MNI-1054 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average and standard deviation across subjects of the variability ((test - retest) / average(test, retest) ) as well as the intraclass correlation (ICC).
Adequacy of the initial scan brain uptake for completion of a retest scan will be based on maximum Standard Uptake value (SUV), where a maximum SUV > 1.5 will be considered sufficient, possibly sufficient between 1.0 and 1.5, and insufficient below 1.0.
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 posted4 Oct 2018
- Study start9 Aug 2018
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers (HV)Studies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Madonia, PA-C, Principal investigator, Invicro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695926
- Sponsor's protocol ID
- [18F]MNI-1054
- Status last verified
- May 2019
- First submitted
- 2 Oct 2018
- Last updated
- 23 May 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Matsuda S, Hattori Y, Kimura H. Drug discovery strategy for TAK-418, a specific inhibitor of LSD1 enzyme activity, as a novel therapy for autism. Adv Pharmacol. 2025;102:267-300. doi: 10.1016/bs.apha.2024.10.017. Epub 2024 Oct 29.
PubMed 39929582
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. 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-1054 as a Marker for LSD1 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03695926
- Acronym / sponsor ID
- [18F]MNI-1054
- Conditions
- Healthy Volunteers (HV)
- Keywords
- HV
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- InvicroUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 4 Oct 2018 (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 primary objective of this protocol is to evaluate [18F]MNI-1054 as a Lysine-specific histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical.
Detailed description
The primary objective of this protocol is to evaluate [18F]MNI-1054 as a Lysine-specific histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical. The specific objectives are:
- To measure the dynamic uptake and washout of [18F]MNI-1054 in brain using positron emission tomography (PET) in healthy volunteers.
- To measure blood metabolites of [18F]MNI-1054 in the healthy volunteers and to perform invasive as well as non-invasive modeling to assess its ability to measure LSD1 in the brain.
- To acquire safety data following injection of [18F]MNI-1054
- Evaluation of [18F]MNI-1054 PET reliability (test/retest) of the tracer parameters in healthy volunteers.
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-1054 | Experimental | Drug: [18F]MNI-1054To measure blood metabolites, dynamic uptake, and washout of [18F]MNI-1054 in brain using positron emission tomography (PET) in healthy volunteers. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Understand the study procedures and agree to participate by providing written informed consent.
- Are willing and able to comply with all study procedures and restrictions.
- Are males or females > 18 years of age and < 50 years of age.
- Are in good health as determined by the investigator based on clinical evaluations including past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and prior to the first dose of study drug.
- Are a current nonsmoker who has not used tobacco- or nicotine-containing products (eg, nicotine patch) for at least 6 months prior to the first dose of study drug or first invasive procedure.
Key exclusion criteria (19 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.
- Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- 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 millisievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines.
- Has a known hypersensitivity to any component of the formulation of [18F]MNI-1054 or related compounds.
- Major surgery, or donation or loss of 400 mL or more of blood within four (4) weeks prior to initial dosing, or longer if required by local regulation.
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-1054Healthy volunteers recruited for the study will undergo a [18F]MNI-1054 PET scan. | Drug | [18F]MNI-1054 |
Primary outcome
Average and standard deviation across subjects of the variability ((test - retest) / average(test, retest) ) as well as the intraclass correlation (ICC).
Time frame: 1 year
Adequacy of the initial scan brain uptake for completion of a retest scan will be based on maximum Standard Uptake value (SUV), where a maximum SUV > 1.5 will be considered sufficient, possibly sufficient between 1.0 and 1.5, and insufficient below 1.0.
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 23 May 2019.
- Derived from this study: PubMed 39929582Matsuda S, Hattori Y, Kimura H. Drug discovery strategy for TAK-418, a specific inhibitor of LSD1 enzyme activity, as a novel therapy for autism. Adv Pharmacol. 2025;102:267-300. doi: 10.1016/bs.apha.2024.10.017. Epub 2024 Oct 29.
- Related InfoLink provided by the sponsor.
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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.
Jennifer Madonia, PA-C 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 Early Phase 1 study testing [18F]MNI-1054 in people with Healthy Volunteers (HV), 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 8 inclusion and 19 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 23 May 2019. 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?
Average and standard deviation across subjects of the variability ((test - retest) / average(test, retest) ) as well as the intraclass correlation (ICC). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695926, which also lists 1 linked publication.
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 23 May 2019.