NCT03695926
Completed
Early Phase 1
An Open-label, Brain Positron Emission Tomography, Phase 0 Study of [18F]MNI-1054 as a Marker for LSD1 in Healthy Subjects
Overview
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Invicro
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Average and standard deviation across subjects of the variability ((test - retest) / average(test, retest) ) as well as the intraclass correlation (ICC).
Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
[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.
Intervention: [18F]MNI-1054 (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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