Single-blind, Randomised, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- •Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702.
研究概览
简要总结
This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a randomized sequence on 5 separate study occasions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Healthy as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, laboratory tests and cardiac monitoring.
- •Male or female between 18 and 55 years of age.
- •A female subject is eligible to participate if she is of non-childbearing potential
- •Body weight > 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.
- •Demonstrates no evidence of mental impairment.
- •No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview
排除标准
- •A positive pre-study drug/alcohol screen.
- •A positive pre-study Hepatitis B , Hepatitis C or HIV.
- •History of regular alcohol consumption.
- •The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- •Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements .
- •History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
- •Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- •Pregnant females, females planning pregnancy or lactating females.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Subjects with a current or a history of psychiatric illness.
- •Subjects with any history of suicidal attempts or behavior.
- •Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products.
- •Consumption of red wine, seville oranges, grapefruit or grapefruit juice (and pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices) from 7 days prior to the first dose of study medication.
研究组 & 干预措施
Cohort 1
Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan
干预措施: GSK1034702 (Drug)
Cohort 1
Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan
干预措施: Placebo (Drug)
Cohort 2
Subjects will be receive GSK1034702 5 mg following the dose escalation plan
干预措施: GSK1034702 (Drug)
Cohort 2
Subjects will be receive GSK1034702 5 mg following the dose escalation plan
干预措施: Placebo (Drug)
结局指标
主要结局
•Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702.
时间窗: 20 weeks
次要结局
- Assessment of the Bond-Lader Visual Analogue Scale.(20 weeks)
- Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone.(20 weeks)
- Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters.(20 weeks)