NCT05985590已完成1 期
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of Multiple Doses of BMS-986278 on the Pharmacokinetics of Combined Oral Contraceptives (Drospirenone/Ethinyl Estradiol) in Healthy Female Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年8月18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
- 37
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.0 and 32.0 kilograms/meter square (kg/m^2), inclusive.
- •Body weight ≥ 45 kg.
- •Healthy females, as determined by physical examination and clinical laboratory assessments (including chemistry, hematology, coagulation, and urinalysis) within the normal range at the screening visit and on Day -1, as applicable.
排除标准
- •Any significant acute or chronic medical illness.
- •Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed (12 months prior to screening).
- •Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, especially eye issues, as determined by the investigator.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Treatment A: DRSP/EE
Experimental
干预措施: Drospirenone/Ethinyl Estradiol (Drug)
Treatment B: BMS-986278/DRSP/EE
Experimental
干预措施: BMS-986278 (Drug)
Treatment B: BMS-986278/DRSP/EE
Experimental
干预措施: Drospirenone/Ethinyl Estradiol (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
时间窗: Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
时间窗: Predose and post-dose up to Day 28
次要结局
- Time of maximum observed concentration (Tmax)(Predose and post-dose up to Day 28)
- Terminal half-life (T-Half)(Predose and post-dose up to Day 28)
- Apparent total body clearance after extravascular administration (CL/F)(Predose and post-dose up to Day 28)
- Number of Participants with Adverse Events (AEs)(Up to Day 53)
- Number of Participants with Serious AEs (SAEs)(Up to Day 53)
- Number of Participants with AEs leading to discontinuation(Up to Day 53)
- Number of Participants with Physical Examination Abnormalities(Up to Day 28)
- Number of Participants with Vital Sign Abnormalities(Up to Day 28)
- Number of Participants with Electrocardiogram (ECG) Abnormalities(Up to Day 28)
- Number of Participants with Clinical Laboratory Abnormalities(Up to Day 27)
研究者
研究点 (1)
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