An Open-label, Non-randomized Study to Investigate the Effects of Twice-Daily Milvexian Administration on the Pharmacokinetics of Single Doses of Midazolam, Ethinylestradiol and Drospirenone in Healthy Adult Females
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Midazolam and 1-hydroxymidzolam
研究概览
简要总结
The purpose of this study is to measure the effect of milvexian given for approximately 2 weeks on (a) how the liver metabolizes other drugs (in this case one called midazolam), and (b) the pharmacokinetics (the way the body absorbs, distributes, and gets rid of a drug) of an oral contraceptive pill in healthy adult females.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of physical examination, medical history, and vital signs, and 12-lead electrocardiography (ECG) performed at screening and on 1 day prior midazolam intervention (Day -1)
- •Healthy on the basis of clinical laboratory tests performed at screening and on Day -1 (screening) of the treatment phase. If the results of the serum chemistry panel, coagulation (activated partial thromboplastin time [aPTT] and prothrombin time [PT]), hematology, or urinalysis
- •Body weight not less than 50.0 kilograms (kg) and body mass index (BMI; weight (kg) per height metered square (kg/m^2) within the range 18.5-30.0 kg/m^2 (inclusive) at screening and Day -1
- •All women must have a negative highly sensitive serum human chorionic gonadotropin (beta-hCG) test at screening and urine pregnancy test on Day -1
- •A woman must be: a. Not of childbearing potential or b. Of childbearing potential and practicing a highly effective method of contraception and agrees to remain on a highly effective method (failure rate of less than [<]1 percentage [%] per year when used consistently and correctly) until 4 days (5 half-lives) after last dose of milvexian-the end of relevant exposure
排除标准
- •History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study intervention to the participant or that could prevent, limit or confound the protocol specified assessments
- •History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study intervention or any of the excipients of milvexian, midazolam, or Drospifem 20 (ethinylestradiol + drospirenone)
- •Clinically significant abnormal values for hematology, coagulation, clinical chemistry or urinalysis at screening or on Day -1 as determined by the investigator or appropriate designee. If any of the following laboratory rules are met at screening or Day -1, the participant should be excluded. A retest is allowed once: hemoglobin or hematocrit < lower limit of normal, platelet count < lower limit of normal, aPTT or PT greater than (>) 1.2 x upper limit of normal (ULN)
- •Received an investigational intervention or used an invasive investigational medical device within 60 days or received a biological product within 3 months, or within a period less than 6 times the drug's half-life, if known, whichever is longer, before the first dose of study intervention or is currently enrolled in an investigational study
- •Has used hormonal contraception injections or implants within 6 months of the first study intervention administration or has used any other hormonal contraception within 30 days of the first study intervention administration on Day 1
研究组 & 干预措施
Milvexian + Midazolam + Ethinylestradiol/Drospirenone
Participants will receive midazolam on Day 1 and Day 19; ethinylestradiol and drospirenone on Day 2 and Day 20; and milvexian from Day 7 to Day 24.
干预措施: Milvexian (Drug)
Milvexian + Midazolam + Ethinylestradiol/Drospirenone
Participants will receive midazolam on Day 1 and Day 19; ethinylestradiol and drospirenone on Day 2 and Day 20; and milvexian from Day 7 to Day 24.
干预措施: Midazolam (Drug)
Milvexian + Midazolam + Ethinylestradiol/Drospirenone
Participants will receive midazolam on Day 1 and Day 19; ethinylestradiol and drospirenone on Day 2 and Day 20; and milvexian from Day 7 to Day 24.
干预措施: Ethinylestradiol (Drug)
Milvexian + Midazolam + Ethinylestradiol/Drospirenone
Participants will receive midazolam on Day 1 and Day 19; ethinylestradiol and drospirenone on Day 2 and Day 20; and milvexian from Day 7 to Day 24.
干预措施: Drospirenone (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Midazolam and 1-hydroxymidzolam
时间窗: Up to Day 19
AUC(0-last) is defined as area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of midazolam and 1-hydroxymidzolam.
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite time (AUC[0-infinity]) of Midazolam and 1-hydroxymidzolam
时间窗: Up to Day 19
AUC(0-infinity) is defined as the area under the plasma concentration-time curve from time 0 to infinite time of midazolam and 1-hydroxymidzolam.
Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol and Drospirenone
时间窗: Up to Day 25
Cmax is defined as the maximum observed plasma concentration of ethinylestradiol and drospirenone.
Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Ethinylestradiol and Drospirenone
时间窗: Up to Day 25
AUC(0-last) is defined as area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of ethinylestradiol and drospirenone.
Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidzolam
时间窗: Up to Day 19
Cmax is defined as the maximum observed plasma concentration of midazolam and 1-hydroxymidzolam.
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Ethinylestradiol and Drospirenone
时间窗: Up to Day 25
AUC(0-infinity) is defined as the area under the plasma concentration-time curve of from time 0 to infinite time ethinylestradiol and drospirenone.
次要结局
- Number of Participants with Abnormalities in Vital Signs(Up to 16 weeks)
- Number of Participants with Adverse Events (AEs) of Interest(Up to 16 weeks)
- Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Milvexian(Up to Day 19)
- Area Under the Plasma Concentration-time Curve of Milvexian over the Dosing Interval (tau) at Steady-state (AUCtau,ss)(Up to Day 19)
- Number of Participants with Adverse Events (AEs)(Up to 16 weeks)
- Number of Participants with Abnormalities in Electrocardiograms (ECGs)(Up to 16 weeks)
- Maximum Observed Plasma Concentration of Milvexian at Steady-state (Cmax,ss)(Up to Day 19)
- Maximum Observed Plasma Concentration (Cmax) of Milvexian(Up to Day 19)
- Number of Participants with Abnormalities in Clinical Laboratory Tests(Up to 16 weeks)