NCT03019289已完成1 期
A Phase I, Open-Label, Single-Dose, Adaptive (S)-(-)-[18F]Fluspidine and [18F]Fallypride Positron Emission Tomography Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease
Prilenia1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年4月19日最近更新:
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
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Sigma-1 Receptor Occupancy
研究概览
简要总结
The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R (optional) in the living human brain. No formal statistical analysis will be conducted
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •In general, good physical health as determined by medical history and psychiatric history, suicidality assessment & physical examination
- •Men who are potentially fertile (not surgically [eg, vasectomy] or congenitally sterile
- •Patients with Huntington's disease (HD): diagnosis of HD and with an onset of HD after 18 years of age
- •Additional criteria apply, please contact the investigator for more information
排除标准
- •The subject has been previously exposed to ionizing radiation or radioactive substances as a result of clinical research or medical treatment in the past 10 years.
- •The subject has a counterindication to having an MRI
- •History of alcohol, narcotic, or any other substance dependence in the past 2 years
- •Additional Exclusion criteria to patients with Huntington's disease:
- •The patient has a severe motor impairment that might cause artifacts.
- •Patients with a known history of Long QT Syndrome or a first degree relative with this condition.
- •Treatment with any investigational product within 6 weeks of screening or patients planning to participate in another clinical study assessing any investigational product during the study.
- •Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
pridopidine
Experimental
Pridopidine (TV-7820) capsules
干预措施: pridopidine (90 mg) (Drug)
结局指标
主要结局
Sigma-1 Receptor Occupancy
时间窗: 2 hours after oral administration of pridopidine
Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-\[18F\]fluspidine
次要结局
- Maximum Plasma Concentration of Pridopidine(PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.)
- Time to Reach Maximum (Peak) Concentration (Tmax)(PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically RemovedBreast CancerNCT06547476Guangdong Provincial People's Hospital40
Unknown
2 期
Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical CancerUterine Cervical NeoplasmsCervical NeoplasmsCervix CancerCervical CancerNCT04096911Buhai Wang20
已完成
1 期
A Study of PDR001 in Combination With LCL161, Everolimus or PanobinostatColorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell CarcinomaNCT02890069Novartis Pharmaceuticals298
已完成
1 期
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) PatientsNon Small Cell Lung CancerNCT00457119Novartis Pharmaceuticals69
招募中
2 期
Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast CancerBreast CancerNCT06472583Maria Sklodowska-Curie National Research Institute of Oncology78