An Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain PDE4 Engagement, Pharmacokinetics and Safety of Single Oral Doses of GSK356278, Using 11C-(R)-Rolipram as a PET Ligand(s)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Positron Gamma-ray emmision & voxel counts
研究概览
简要总结
This study will investigate if a new experimental drug to treat Huntington's Disease gets into the brain. If it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. The study will involve healthy male volunteers.
详细描述
This is an open label, non-randomized, adaptive design PET occupancy study in healthy adult males. The primary aim of this study is to describe the relationship between plasma concentrations and brain PDE4 occupancy of GSK356278 over time. Up to 24 healthy volunteers may be administered single doses of GSK356278 in order to obtain 12 evaluable complete data sets of occupancy estimates. This study will help to optimize the dose selection for future clinical studies with GSK356278.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteer, aged 22-55 years.
- •Normal blood pressure, laboratory values, and body mass index
- •Willing to agree to study procedures & contraception requirements
- •Capable of giving written informed consent
排除标准
- •Any evidence of disease that would preclude participation in the clinical study (includes sexually transmitted diseases, exessive alcohol consumption, and substance abuse).
- •Previously involved in another clinical trial within 3 months prior to scheduled administration of study drug
- •Suffers from claustrophobia
- •Any contraindications for MRI scanning (e.g. pacemaker, metal implants or fillings)
研究组 & 干预措施
GSK356278
Investigational drug
干预措施: GSK356278 (Drug)
GSK356278
Investigational drug
干预措施: Rolipram (Drug)
结局指标
主要结局
Positron Gamma-ray emmision & voxel counts
时间窗: 60 minutes
Brain regions of interest and associated radionuclitide-activity
systemic plasma concentration
时间窗: 24 hours
serial sampling: GSK356278 concentration expressed as mass per unit of volume
次要结局
- Heart rate - bpm(72 hours)
- ECG - 12-Lead & Telemetry(24 & 72 hours)
- Blood pressure - mm/Hg(24 hours)