Emotional Processing in Healthy Male Volunteers Treated With GSK424887. A Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Multiple emotional and psychometric battery of tests
研究概览
简要总结
This will be a phase I, single centre, randomised, double blind, double-dummy, placebo controlled, parallel group single-dose study in healthy volunteers. The purpose of this study is to assess the effect of a single-dose administration of GSK424887, a potent, selective competitive antagonist of the human Neurokinin 1 (NK1) receptor and a potent inhibitor of the human serotonin transporter (SERT), at the maximum dosage of 100 mg versus placebo and versus citalopram (20 mg) on emotional processing in healthy male volunteers. Pharmacokinetics and safety following oral administration of GSK424887 will be also evaluated. An Emotional Test Battery (ETB) previously used to characterise the effects of antidepressants on positive and negative emotion processing in Healthy Volunteers and patients will be used. We hypothesise that GSK424887 will modulate emotional information processing acutely. We anticipate that these effects may be manifest at sub-effective levels of NK1 and SERT receptor occupancy, thus providing pharmacodynamic evidence of the synergistic interaction of the two mechanisms in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males with no neurological, or history of psychiatric illness
- •Aged between 18 and 45 years
- •Agree to use contraception
- •BMI range of 18 to 33 kg/m²
- •Fluent English speakers
- •Non smoker or light smoker
排除标准
- •Positive pre-study drug/alcohol screen or regular alcohol consumption
- •Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- •On prescription or non prescription drug
- •Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- •Consumption of large amounts of caffeinated drinks
- •Significant hearing impairment
- •Previous experience of the emotional test battery experimental procedures
研究组 & 干预措施
Citalopram
Marketed comparitor
干预措施: Citalopram (Drug)
Investigational Medicinal Product
GSK424887
干预措施: GSK424887 (Drug)
Placebo To Match Treatment
Placebo control
干预措施: Plactebo To Match (Drug)
结局指标
主要结局
Multiple emotional and psychometric battery of tests
时间窗: < 1 day
Adverse Events, laboratory values, vital signs, ECGs
时间窗: < 1 day
次要结局
未报告次要终点
