Single-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802 and Its Interaction With Food in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily or twice daily and their relationship with the GSK1014802 exposure after a single dose.
研究概览
简要总结
GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models.
This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy male or female subjects. In addition, the effect of food on the pharmacokinetics of GSK1014802 will be investigated.
详细描述
This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now been acquired by Biogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 medical history, physical examination, laboratory tests and cardiac monitoring.
- •Male or female (of non-child bearing potential) subjects aged between 18 and 55 years.
- •A female subject is eligible to participate if she is of non-childbearing potential.
- •Male subjects must agree to use an acceptable form of contraception.
- •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.
- •QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
排除标准
- •The subject has a positive pre-study drug/alcohol screen.
- •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- •A positive test for HIV antibody.
- •History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females).
- •Current or past history of symptomatic orthostatic hypotension or history of unexplained vasovagal episode(s).
- •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 (60 h) 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 (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- •History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- •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.
- •Lactating females.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- •. Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- •History of known or suspected seizures, including infantile febrile, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits).
研究组 & 干预措施
Cohort 2
干预措施: GSK1014802 (Drug)
Cohort 1
干预措施: Placebo (Drug)
Cohort 1
干预措施: GSK1014802 (Drug)
Cohort 4
干预措施: Placebo (Drug)
Cohort 4
干预措施: GSK1014802 (Drug)
Cohort 3
干预措施: Placebo (Drug)
Cohort 3
干预措施: GSK1014802 (Drug)
Cohort 2
干预措施: Placebo (Drug)
结局指标
主要结局
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily or twice daily and their relationship with the GSK1014802 exposure after a single dose.
时间窗: 14-28 days
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily with or without food.
时间窗: 14-28 days
Safety and tolerability will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters.
时间窗: 14-28 days
Blood concentrations of GSK1014802 following a single oral dose of GSK1014802.
时间窗: 1 day
次要结局
- Bond-Lader VAS scale(14-28 days)