NCT02448212已完成1 期
A Phase 1 Receptor Occupancy Study Using Positron Emission Tomography to Investigate Novel Ligand [11C]TASP0410699 Alone and Following Single Oral Dose Administrations of TS-121 in Healthy Adult (Male) Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Positron emission tomography measure (receptor occupancy)
研究概览
简要总结
The purpose of this study is to evaluate the binding of a novel tracer, [11C]TASP0410699, using Positron Emission Tomography (PET) scans with or without dosing of TS-121
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males 18 - 55 years of age (at time of initial informed consent)
- •Body weight ≥ 50 kg
- •Body Mass Index (BMI) 18 - 30 kg/m2
- •Male subjects with partners of childbearing potential must agree to use appropriate and effective measures of contraception for 90 days following drug administration
排除标准
- •Prescription, over-the-counter or herbal medications, supplements, within 14 days before the study.
- •Clinically significant abnormal electrocardiogram, physical examination, or hematology, biochemistry, hormone, or urinalysis values at screening & baseline.
- •Significant history &/or presence of hepatic, renal, cardiovascular, hemodynamic, pulmonary, gastrointestinal, hematological, CNS, immunologic, ophthalmologic, metabolic, endocrine, or oncological disease or condition within last 5 years.
- •Current use of tobacco or tobacco-containing products, recent history of alcohol or drug abuse OR positive urine screen for alcohol or controlled substances at screening or baseline.
- •History &/or current evidence of serologic positive results for hepatitis B or C, or HIV.
- •Donation or acute loss of 450 milliliters or more of blood or plasma, within 60 days of the study.
- •Any subject who has received treatment with a non-FDA approved drug within 30 days of study screening.
- •Subjects who suffer from claustrophobia.
- •Current, past, or anticipated exposure to radiation in the workplace or participation in other research studies involving ionizing radiation that would exceed the yearly dose limits for normal subjects.
研究组 & 干预措施
PART 1 (Test/Retest)
Experimental
Dosing with [11C]TASP0410699 for PET imaging without dosing of TS-121
干预措施: Positron Emission Tomography (PET) (Radiation)
PART 1 (Test/Retest)
Experimental
Dosing with [11C]TASP0410699 for PET imaging without dosing of TS-121
干预措施: [11C]TASP0410699 (Drug)
PART 2 (PET Receptor Occupancy Study)
Experimental
Dosing with [11C]TASP0410699 for PET imaging with dosing of TS-121
干预措施: [11C]TASP0410699 (Drug)
PART 2 (PET Receptor Occupancy Study)
Experimental
Dosing with [11C]TASP0410699 for PET imaging with dosing of TS-121
干预措施: Positron Emission Tomography (PET) (Radiation)
PART 2 (PET Receptor Occupancy Study)
Experimental
Dosing with [11C]TASP0410699 for PET imaging with dosing of TS-121
干预措施: TS-121 (Drug)
结局指标
主要结局
Positron emission tomography measure (receptor occupancy)
时间窗: Day 1 through Day 3
次要结局
- Pharmacokinetic parameters of TS-121(Day 1 through Day 3)
- Composite safety as assessed by clinical laboratory tests, 12-lead ECG, vital signs, adverse events and physical examinations(up to Day 11)
研究者
研究点 (1)
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