NCT03262740已完成1 期
The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2017年9月11日最近更新:
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
- 58
- 试验地点
- 2
- 主要终点
- Maximum concentration (Cmax) derived from plasma concentration versus time
研究概览
简要总结
The purpose of this study is to investigate the effect of BMS-986195 in combination with an oral contraceptive in healthy female patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive,
- •Weight ≥ 50 kg
- •Negative result for tuberculosis (TB) as evidenced by a QuantiFERON-TB Gold Plus test at screening, or documentation of a negative result within 4 weeks before Cycle 1, Day 1
- •Women of childbearing potential with intact ovarian function, on a stable regimen of combination birth control containing EE without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to Cycle 1 Day -1
- •Subjects aged 21 years or older must have a normal Pap smear result within 3 years before Cycle 1 Day 1 (a Pap smear may be performed at screening if no result is available); a finding of abnormal squamous cells of unknown significance (ASCUS) is allowed provided it is an initial finding and not a follow up from an initial finding of ASCUS
排除标准
- •Exposure to an investigational agent within 12 weeks before Cycle 1 Day 1
- •Subjects who are pregnant or breastfeeding
- •Any significant acute or chronic medical illness including infection, any active infection, febrile illness within 7 days before Cycle 1, Day 1, or any condition that could predispose the subject to infection
- •History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic urinary tract infection is 2 episodes within 6 months)
- •Any serious acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
- •Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (eg, history of splenectomy, primary immunodeficiency, etc)
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986195 and Oral Contraceptive
Experimental
Oral administration of contraceptive, then progress to combination
干预措施: BMS-986195 (Drug)
BMS-986195 and Oral Contraceptive
Experimental
Oral administration of contraceptive, then progress to combination
干预措施: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol) (Drug)
结局指标
主要结局
Maximum concentration (Cmax) derived from plasma concentration versus time
时间窗: Approximately 1 day
Area under the plasma concentration-time curve to the end of the dosing period [AUC(tau)] derived from plasma concentration versus time
时间窗: Approximately 1 day
次要结局
- Serious adverse events measured by incidence(Approximately 86 days)
- Adverse events measured by incidence(Approximately 86 days)
研究者
研究点 (2)
Loading locations...
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