Phase 0 Study of [18F]MNI-1054 as a Marker for LSD1
赞助:
Invicro
合作者:
信息的提供 (责任方):
，
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | August 9, 2018 | ||
| 预计主要完成日期 | September 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
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 SUV, where a maximum SUV > 1.5 will be considered sufficient, possibly sufficient between 1.0 and 1.5, and insufficient below 1.0. |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | Phase 0 Study of [18F]MNI-1054 as a Marker for LSD1 | ||
| 正式标题 ICMJE | An Open-label, Brain Positron Emission Tomography, Phase 0 Study of [18F]MNI-1054 as a Marker for LSD1 in Healthy Subjects | ||
| 简要概况 | The primary objective of this protocol is to evaluate [18F]MNI-1054 as a Lysine-specific histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical. |
||
| 详细说明 | 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. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Early Phase 1 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Other |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
6 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 1, 2019 | ||
| 预计主要完成日期 | September 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | 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 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. - 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-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 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. | ||
| 性别 |
|
||
| 年龄 | 最小年龄：18 Years ，最大年龄：50 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | ， | ||
| 研究赞助商 ICMJE | Invicro | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | |||
| 验证日期 | October 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号