Phase 1, Randomised, Open-label, 3-way Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics (With Food Effect), and Relative Bioavailability of NTP42:KVA4 Given as a Capsule, Compared With a Liquid, in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
研究概览
简要总结
This Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. In two of the dose sessions, volunteers will be fasted where, in one, they will be given the NTP42:KVA4 capsule and, in another, they will be given NTP42:KVA4 in oral liquid form. To test the effect of food on drug absorption (PK), the volunteers will also be given the NTP42:KVA4 capsule after eating a full breakfast.
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
- None
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
- •A body mass index (BMI) in the range 18.0-30.0
- •Ability & willingness to provide written consent
排除标准
- •Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening.
- •History of bleeding disorders, coagulation variables or abnormal blood cell count.
- •History of chronic illness.
- •Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness.
- •History of adverse reaction or allergy to any drug.
- •Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any other medicine that affects platelet function or coagulation, or any prescription medicine, during the 28 days before the first dose of trial medication.
- •History of drug or alcohol abuse
- •Smoker or use of nicotine-containing products
- •Blood pressure or heart rate at screening outside normal ranges.
结局指标
主要结局
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
时间窗: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
Pharmacokinetic parameter: Area under the curve (AUC)
Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
时间窗: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
Pharmacokinetic parameter: Area under the curve (AUC)
Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers
时间窗: Up to 48-hour post-dose
Adverse events (AEs)
次要结局
- Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers(Predose, 2-, 6-, 24- & 48-hours post-dosing)