NCT02832180已完成1 期
The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET
研究概览
简要总结
This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 Informed Consent
- •Target population: Healthy females with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests that are willing to switch to Loestrin during the study.
- •Body Mass Index (BMI) between 18 to 32 kg/m
- •Women of childbearing potential with intact ovarian function and history of regular menstrual cycles must have been on a stable regimen of combination of birth control containing ethinyl estradiol without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -
- •Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs (53 days) plus 5 half-lives of BMS-986142 (3 days) plus 30 days (duration of ovulatory cycle) for a total of 86 days.
排除标准
- •History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
- •History of jaundice or irregular bleeding associated with taking oral contraceptives, frequent headaches, cerebrovascular or coronary-artery disease, retinal vascular lesions, cancer of the breast or endometrium, deep venous thrombosis, pulmonary embolism, stroke, transient ischemic attack, or phlebitis.
- •Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
- •History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
研究组 & 干预措施
Daily single dose of OC containing EE and NET
Experimental
Daily single dose of OC Containing EE and NET alone.
干预措施: OC containing EE and NET (Drug)
Daily single dose of OC in combination with BMS-986142
Experimental
Daily single dose of OC containing EE and NET in combination with BMS-986142.
干预措施: OC containing EE and NET (Drug)
Daily single dose of OC in combination with BMS-986142
Experimental
Daily single dose of OC containing EE and NET in combination with BMS-986142.
干预措施: BMS-986142 (Drug)
结局指标
主要结局
Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET
时间窗: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve (AUC) of EE and NET
时间窗: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Maximum observed plasma concentration (Cmax) of EE and NET
时间窗: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
次要结局
- Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death.(Cycle 1 Day 1 to Cycle 2 Day 25; For SAEs up to 30 days post discontinuation of dosing or participation.)
研究者
研究点 (2)
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