NCT04016753已完成1 期
The Effect of BMS-986256 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年8月5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
- 32
- 试验地点
- 1
- 主要终点
- Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)
研究概览
简要总结
A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must be a non- smoking genetically female, who has normal renal function, willing to use Loestrin, and of childbearing Potential with intact ovarian function.
- •Participants must be healthy, defined as having no clinically significant active or ongoing medical condition Weighing less than or equal to 50 kg and a body mass index between 18.0 and 32.0kg inclusive at screening.
- •Participant must have a negative QuantiFeron- TB Gold test at screening and have a normal pap smear result within 3 years.
排除标准
- •Participants who are involuntarily incarcerated, have a significant Chronic medical illness or a history of relevant drug allergy to immunologic or related compounds.
- •Any serious bacterial, fungal, or viral infection within 3 months or a history of recurrent or chronic infection or Risk for TB.
- •A history of any medical condition specifically related to the use of hormonal contraceptives as well as an average intake of more than 21 units of alcohol per week.
研究组 & 干预措施
Monotherapy
Experimental
干预措施: BMS-986256 (Drug)
Monotherapy
Experimental
干预措施: Loestrin (Drug)
结局指标
主要结局
Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)
时间窗: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Area under the plasma concentration-time curve over the dosing interval AUC(TAU) of NET
时间窗: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
时间窗: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Area under the plasma concentration-time curve over the dosing interval AUC(TAU)of (EE)
时间窗: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
次要结局
- Incidence of Serious Adverse Events (SAEs)(Up to 28 weeks)
- Incidence of Adverse Events (AEs)(Up to 28 weeks)
- Vital signs of body temperature(up to 28 weeks)
- Serology clinical lab assessment of blood(up to 28 weeks)
- Hematology clinical lab assessments of blood(up to 28 weeks)
- Urinalysis clinical lab assessment(up to 28 weeks)
- Vital signs of blood pressure(up to 28 weeks)
- Vital signs of respiratory rate(up to 28 weeks)
- Number of Participants with abnormal physical examination findings(up to 28 weeks)
研究者
研究点 (1)
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