A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of V81444 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Evaluate the safety of V81444 by assessing the frequency of adverse events
研究概览
简要总结
A double-blind, randomised, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male volunteers
详细描述
Part A - Single Ascending Dose (SAD) Double-blind, randomised, placebo-controlled, single ascending dose study.
Each study subject will participate in a screen visit, three identical treatment periods, in each of which they will receive a single oral dose of V81444 or placebo in accord-ance with the randomisation schedule, and one post-study visit.
In each treatment period, subjects will be admitted the day before dosing (Day -1) and, subject to satisfactory medical review, discharged in the morning, 4 days later (Day 4).
Part B - Multiple Ascending Dose (MAD) Double-blind, randomised, placebo-controlled, parallel group, multiple ascending dose study
Each study subject will participate in a screen visit, one treatment period in which they will receive repeated oral doses of V81444 or placebo in accordance with the randomisation schedule, and one post-study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 male volunteers: aged 18 to 45 years, in good general health as determined by medical history, physical examination and screening investigations, and taking no regular medication. Confirmation to be sought for all volunteers that their general practitioner has provided an acceptable medical history.
排除标准
- •have a history or evidence of clinically significant gastrointestinal disease, including ulcers, gastro-oesophageal reflux disease or gastritis
- •any known malformations that would make OGD difficult or unsafe(Part B only)
- •have taken V81444 in any previous investigational study
- •have taken any restricted concomitant medication
- •have multiple drug allergies or be allergic to any of the components of V81444 study medication or its matching placebo or midazolam (Part B only)
- •in the 4 calendar months before study drug administration have smoked more than 5 cigarettes per day have consumed more than 28 units of alcohol per week have donated blood or plasma in excess of 500 mL been exposed to any new investigational agent or any other adenosine A2A receptor antagonist used non-steroidal anti-inflammatory drugs regularly had a new tattoo or body piercing
- •have any clinically relevant abnormal findings at screening and/or admission
- •intend to father a child with their female partner or through sperm donation within 4 months after the last dose of study medication
研究组 & 干预措施
Single Ascending Dose
Single Ascending Doses of V81444 compared to placebo
干预措施: V81444 (Drug)
Multiple Ascending Doses
Multiple ascending doses of V81444 compared to placebo
干预措施: V81444 (Drug)
结局指标
主要结局
Evaluate the safety of V81444 by assessing the frequency of adverse events
时间窗: From screening until 7 days post dosing
Evaluate the safety of V81444 by assessing laboratory safety assessments
时间窗: Lab safety assessments are taken at screening, day minus 1, 24h and 72h and post dosing
Evaluate the safety of V81444 by assessing ECG
时间窗: Taken at screening and until 7 days post dosing
Evaluate the safety of V81444 by assessing vital signs
时间窗: Taken at screening and until 7 days post dosing
Evaluate the safety of V81444 by assessing physical examination
时间窗: Taken at screening and post dosing
次要结局
未报告次要终点