NCT02157467已完成1 期
The Effect of Coadministration of BMS-955176 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination
研究概览
简要总结
The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed Written Informed Consent a) The signed informed consent form
- •Target population
- •a) Healthy female subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
- •b) Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive, at screening and Day -
- •BMI = weight (kg)/[height (m)]2
- •c) Weight greater than or equal to 45 kg
- •d) Subject Reenrollment: This study permits the reenrollment of a subject that has discontinued study as a pretreatment failure (ie, has not been treated). If reenrolled, the subject must be reconsented
- •Age and Reproductive Status
- •a) Women, 18 to 40 years of age, inclusive
- •b) Women of childbearing potential (WOCBP) with intact ovarian function as determined by medical history and history of regular menstrual cycles, and who have been on a stable regimen of Ortho Cyclen for at least 2 consecutive months without evidence of breakthrough bleeding or spotting, or subjects who have been using a stable regimen of another combination oral contraceptive containing EE for at least two months prior to dosing on Day 1 of Cycle 1 and willing to switch to Ortho Cyclen for the total duration of the study (approximately 78 days)
- •c) Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to dosing on Day 1 of Cycle 1
- •d) Women must not be breastfeeding
排除标准
- •Medical History and Concurrent Diseases
- •a) Any significant acute or chronic medical illness
- •b) History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
- •c) Current or recent (within 3 months of dosing on Day 1 of Cycle 1) gastrointestinal disease
- •d) Any major surgery within 4 weeks of dosing on Day 1 of Cycle 1
- •e) Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
- •f) Donation of > 400 mL to a blood bank or in a clinical study (except a screening visit) within 8 weeks of dosing on Day 1 of Cycle 1
- •g) Blood transfusion within 4 weeks of dosing on Day 1 of Cycle 1
- •h) Inability to tolerate oral medication
- •i) Inability to be venipunctured and/or tolerate venous access
- •j) Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1 of Cycle 1)
- •k) Recent (within 6 months of dosing on Day 1 of Cycle 1) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
- •l) Any other sound medical, psychiatric, and/or social reason as determined by the investigator
研究组 & 干预措施
Arm 1: NGMN/EE + BMS-955176
Experimental
Cycle 1- Active Ortho Cyclen QD on Days 1 to 21. Inert Ortho Cyclen tablets on Days 22 to 28
Cycle 2- Active Ortho Cyclen QD alone on Days 29 to 39 (11 days), followed by concomitant administration of active Ortho Cyclen QD + BMS-955176 80 mg QD on Days 40 to 49 (10 days)
干预措施: Ortho Cyclen (Drug)
Arm 1: NGMN/EE + BMS-955176
Experimental
Cycle 1- Active Ortho Cyclen QD on Days 1 to 21. Inert Ortho Cyclen tablets on Days 22 to 28
Cycle 2- Active Ortho Cyclen QD alone on Days 29 to 39 (11 days), followed by concomitant administration of active Ortho Cyclen QD + BMS-955176 80 mg QD on Days 40 to 49 (10 days)
干预措施: BMS-955176 (Drug)
结局指标
主要结局
Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination
时间窗: Before dosing (0 hour) through 24 hours after administration on Days 21 and 49
次要结局
- Serum progesterone measurements(Day 14, 21, 35, and 42)
- Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.(Two to three months)
- Trough blood samples collected for BMS-955716(Days 48, 49, 50)
研究者
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