A Phase I, Open-Label, Randomized 3-Period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Interactions Between YM150 on Naproxen at Steady-State
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Assessment of pharmacodynamics of naproxen
研究概览
简要总结
The primary objective of this study is to evaluate whether naproxen and darexaban which have different effects on blood coagulation influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18.5-30.0 kg/m2
- •Male subjects must be non-fertile, i.e. surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies
排除标准
- •Known or suspected hypersensitivity to darexaban or naproxen or any components of the formulation used
- •A contra-indication for the use of naproxen
- •Any of the liver function tests (i.e. ALT, AST and bilirubin) above the upper limit of normal at repeated measures
- •Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator.
- •Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- •Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)
- •Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit
- •Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
- •Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or more than 21 units (210 g) of alcohol per week within the 3 months prior to study
- •Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life
研究组 & 干预措施
Treatment arm A
darexaban, wash-out, naproxen, wash-out, combination therapy
干预措施: darexaban (Drug)
Treatment arm A
darexaban, wash-out, naproxen, wash-out, combination therapy
干预措施: Naproxen (Drug)
Treatment arm B
darexaban, wash-out, combination therapy, wash-out, naproxen
干预措施: darexaban (Drug)
Treatment arm B
darexaban, wash-out, combination therapy, wash-out, naproxen
干预措施: Naproxen (Drug)
Treatment arm C
naproxen, wash-out, darexaban, wash-out, combination therapy
干预措施: darexaban (Drug)
Treatment arm C
naproxen, wash-out, darexaban, wash-out, combination therapy
干预措施: Naproxen (Drug)
Treatment arm D
naproxen, wash-out, combination therapy, wash-out, darexaban
干预措施: darexaban (Drug)
Treatment arm D
naproxen, wash-out, combination therapy, wash-out, darexaban
干预措施: Naproxen (Drug)
Treatment arm E
combination therapy, wash-out, naproxen, wash-out, darexaban
干预措施: darexaban (Drug)
Treatment arm E
combination therapy, wash-out, naproxen, wash-out, darexaban
干预措施: Naproxen (Drug)
Treatment arm F
combination therapy, wash-out, darexaban, wash-out, naproxen
干预措施: darexaban (Drug)
Treatment arm F
combination therapy, wash-out, darexaban, wash-out, naproxen
干预措施: Naproxen (Drug)
结局指标
主要结局
Assessment of pharmacodynamics of naproxen
时间窗: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two
次要结局
- Assessment of pharmacodynamics of darexaban(Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two)
- Pharmacokinetics of darexaban assessed by plasma concentration(Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with naproxen)
- Pharmacokinetics of naproxen assessed by plasma concentration(Plasma samples are taken until 12 hours after four days of dosing of naproxen, or the combination with darexaban)
- Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events(6 days (for treatment periods with darexaban) or 4 days. (naproxen alone))