NCT01923025已完成1 期
A Single Centre, Open Label Study to Characterize the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 After a Single Dose in Healthy Male Volunteers Using [11C]IMA107 Positron Emission Tomography
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
- 9
- 主要终点
- Pharmacodynamics: Brain PDE10 occupancy by RO5545965
研究概览
简要总结
This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission tomography (PET).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, 25 to 50 years of age, inclusive; healthy status is defined by absence of evidence of any active or chronic disease
- •Body mass index (BMI) 18 to 30 kg/m2 inclusive
- •Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method (i.e. condom), for the duration of the study and for 30 days after the last dose
排除标准
- •History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer or cirrhosis
- •History of clinically significant hypersensitivity or allergic drug reactions
- •Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
- •Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
- •Positive for hepatitis B, hepatitis C, or HIV infection
- •Evidence of significant cardiovascular disease or disorder
- •Participation in an investigational drug or device study within 3 months prior to first administration of the study drug or within 6 times the elimination half-life, whichever is longer
- •Previous inclusion in a research and/or medical protocol or any clinical procedures involving nuclear medicine, PET, occupational exposure to ionizing radiation or radiological investigations with significant exposure to radiation, excluding dental X-ray and common X-rays of chest or extremities
- •Subject has any condition that would prevent an MRI from accurately or safely being performed [eg, claustrophobia, cardiac pacemaker, metallic implants or clips]
- •Subject unable to lie on his back in the PET or MRI scanner for a period of 90 minutes
- •Contraindication for arterial cannulation
- •Unsuitable veins for repeated venipuncture
研究组 & 干预措施
RO5545965
Experimental
干预措施: RO5545965 (Drug)
结局指标
主要结局
Pharmacodynamics: Brain PDE10 occupancy by RO5545965
时间窗: up to Day 2
PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations
时间窗: up to Day 2
次要结局
- Safety: Incidence of adverse events(up to 12 days)
- Pharmacokinetics: Plasma concentrations of RO5545965(up to Day 5)
研究者
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