NCT05065541已完成1 期
A Phase 1, Open-label, Multi-part Positron Emission Tomography (PET) Imaging Study to Evaluate the Biodistribution and Radiation Dosimetry of the Monoacylglycerol Lipase (MGLL) PET Ligand [18F]T-401 and to Evaluate Fatty Acid Amide Hydrolase (FAAH) and MGLL Enzyme Availability in the Central Nervous System Using [11C]MK-3168 and [18F]T-401 PET Ligands Before and After Oral Administration of Single and Multiple Doses of CC-97489 in Healthy Adult 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
- 发起方
- Celgene
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Radiation dosimetry calculated from PET-CT images
研究概览
简要总结
The purpose of this study is to evaluate enzyme availability in the central nervous system before and after CC-97489 administration in healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a Body Mass Index (BMI) of 18.0 to 33.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2
- •Must be healthy based on medical history, physical examination (PE), clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) at screening and check-in
排除标准
- •Has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •Is pregnant or breastfeeding
- •Is part of the study site staff personnel or a family member of the study site staff
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part 1
Experimental
干预措施: [18F]T-401 (Drug)
Part 2
Experimental
干预措施: CC-97489 (Drug)
Part 2
Experimental
干预措施: [18F]T-401 (Drug)
Part 2
Experimental
干预措施: [11C]MK-3168 (Drug)
Part 3
Experimental
干预措施: CC-97489 (Drug)
Part 3
Experimental
干预措施: [18F]T-401 (Drug)
结局指标
主要结局
Radiation dosimetry calculated from PET-CT images
时间窗: 1 day
Change from baseline in VT in the brain based on PET scans.
时间窗: Up to 14 days
Calculated % Injected Dose in brain and other key organs and tissues
时间窗: 1 day
Calculated Standard Uptake Volume in brain and other key organs and tissues
时间窗: 1 day
Change from baseline in SUV in the brain based on PET scans
时间窗: Up to 14 days
次要结局
- Pharmacokinetics - Maximum observed plasma concentration (Cmax)(Up to 19 days)
- Pharmacokinetics - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)(Up to 19 days)
- Incidence of AEs(Up to 28 days after the last dose)
- Incidence of clinically significant changes in vital signs: Body temperature(Day 21)
- Incidence of clinically significant changes in vital signs: Respiratory rate(Day 21)
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests(Up to Day 18)
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests(Up to Day 18)
- Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)(Up to 19 days)
- Incidence of clinically significant changes in ECG parameters: QTcF interval(Day 21)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to Day 18)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval(Day 21)
- Incidence of clinically significant changes in ECG parameters: QRS interval(Day 21)
- Incidence of clinically significant changes in ECG parameters: QT interval(Day 21)
- Incidence of clinically significant changes in vital signs: Blood pressure(Day 21)
- Incidence of clinically significant changes in vital signs: Heart rate(Day 21)
- Incidence of serious adverse events (SAEs)(Up to 28 days after the last dose)
研究者
研究点 (1)
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