A Double-blind, Placebo-controlled, Randomized Cross-over Single Dose Escalation Study and a Double-blind, Placebo-controlled, Randomised Parallel Group 7-days Once Daily Repeat Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral H1/H3 Dual Antagonist Compound in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
研究概览
简要总结
This study is designed to assess the safety and tolerability of single, escalating oral doses and repeat oral doses (7 days, once daily) of GSK835726 in healthy male subjects
详细描述
A double-blind, placebo controlled, randomized cross-over single dose escalation study and a double-blind, placebo controlled, randomised parallel group 7-days once daily repeat dose study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of oral H1/H3 dual antagonist compound in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subjects receiving treatment in cohort I
Eligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I.
干预措施: GSK835726 (Drug)
Subjects receiving treatment in cohort I
Eligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I.
干预措施: Placebo (Drug)
Subjects receiving GSK835726 in cohort II
Eligible subjects will receive repeat doses of GSK835726 once daily for 7 days.
干预措施: GSK835726 (Drug)
Subjects receiving placebo in cohort II
Eligible subjects will receive repeat doses of placebo once daily for 7 days.
干预措施: Placebo (Drug)
Subjects receiving treatment in cohort III
Eligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III.
干预措施: GSK835726 (Drug)
Subjects receiving treatment in cohort III
Eligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III.
干预措施: Placebo (Drug)
结局指标
主要结局
ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
时间窗: during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
Heart rate and blood pressure changes over 24 hours after dosing in single and repeat dose cohorts
时间窗: over 24 hours after dosing in single and repeat dose cohorts
次要结局
- time to maximum observed plasma drug concentration (tmax), apparent clearance (CL/F) and terminal half life (t1/2) following single and repeat oral dosing.(over 24 hours after dosing)
- Changes in histamine-induced wheal and flare measurements(over 24 hours after dosing)
- Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)(over 24 hours after dosing)
- Derived pharmacokinetic parameters for GSK835726 including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-¥)), maximum observed plasma drug concentration (Cmax),(over 24 hours after dosing)