Assessment of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
研究概览
简要总结
The purpose of this study is to evaluate the biodistribution, safety and tolerability of a single dose of [18F]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy with no clinically relevant finding on physical examination at screening and prior to radiopharmaceutical administration
- •Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 30 days after the final dose
- •Male participants with partners of childbearing potential must commit to the use of two methods of contraception for the study duration and 90 days after the last dose
- •Male participants must not donate sperm for the duration of the study and 90 days after the last dose
- •Participants must have both Japanese parents and all Japanese grandparents
排除标准
- •Participants with any significant medical disorder or disease expected to interfere with the study
- •Current or prior history (within a six-month period) of exposure to nicotine products
- •History of drug or alcohol abuse within 12 months prior to screening
- •Prior participation in other research protocols or clinical care in the last year, such that radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSv), the allowable annual limit for research participants as established by the US Federal Guidelines
- •Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing
- •Use of over the counter (OTC) medication, dietary supplements, or vitamins, within 2 weeks prior to initial dosing
- •Known hypersensitivity to any component of the formulation of [18F]GTP1 or related compounds
- •Major surgery, or donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing
- •History of immunodeficiency diseases, including positive human immunodeficiency virus (HIV) test
- •Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody
- •Women who are pregnant, lactating or breastfeeding
- •Unsuitable veins for repeated venipuncture
研究组 & 干预措施
[18F]GTP1
Participants will receive a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
干预措施: [18F]GTP1 (Diagnostic Test)
结局指标
主要结局
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
时间窗: Day 1
Decay corrected \[18F\]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).
Source Organ Residence Time (Total Number of Disintegrations)
时间窗: Day 1
Source organ uptake and washout with calculation of total number of disintegrations (or residence time, or kinetic values) using the area under the time-activity curve divided by the injected dose of radiopharmaceutical
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
时间窗: Day 1
Radiation absorbed dose estimates based on the Medical Internal Radiation Dose (MIRD) methodology utilizing urine data and International Commission on Radiological Protection (ICRP) gastrointestinal (GI) tract kinetics
Percentage of Participants With Adverse Events
时间窗: Up to 5 days
An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition, even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation during any phase of the study. Medical conditions/diseases present before starting study drug are only considered AEs if they worsen after starting study drug. Abnormal laboratory values or test results constitute AEs only if they induce clinical signs or symptoms, are considered clinically significant, or require therapy.
次要结局
未报告次要终点