A Double-blind, Placebo-controlled Dose Response Study to Investigate Pharmacodynamics and Pharmacokinetics of Single and Repeated Oral Doses of VA106483 in Elderly Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vantia Ltd
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Pharmacodynamic profile of VA106483
研究概览
简要总结
A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.
详细描述
VA106483 is a selective vasopressin V2 receptor agonist which is currently under development for the treatment of nocturia in males. This study examines the pharmacological action of VA106483 on markers of clinical efficacy (urine volumes and osmolality) and safety markers (coagulation factors and haemodynamics). The study will also assess the pharmacokinetics in the study population. The study design includes both cross-over and parallel phases so that pharmacodynamic and pharmacokinetic parameters can be assessed following both single and repeat dosing. Three dose levels will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males 65 years and above with history of nocturia
排除标准
- •Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
- •Participation in any other clinical study within 30 days
- •Intake of non-prescription medication within 14 days
研究组 & 干预措施
VA106483 8 mg
干预措施: VA106483 (Drug)
Sugar pill
干预措施: Sugar pill (Drug)
VA106483 2 mg
干预措施: VA106483 (Drug)
VA106483 4 mg
干预措施: VA106483 (Drug)
结局指标
主要结局
Pharmacodynamic profile of VA106483
次要结局
- Pharmacokinetic profile of VA106483
- Safety and tolerability of VA106483