NCT05579574已完成1 期
An Open-Label, Single-Sequence, Crossover Study to Investigate the Interaction of Multiple Doses of BMS-986322 at Steady State and Multiple Doses of a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年10月21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
- 42
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET
研究概览
简要总结
The purpose of this study is to evaluate the effect of multiple doses of BMS-986322 on the pharmacokinetics (PK) of Loestrin components in healthy female participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Healthy participants, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the investigator would compromise the conduct, results, or interpretation of the study findings.
- •Have a negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 4 weeks prior to the start of study intervention.
- •Have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter (mL)/minute (min)/1.732m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
排除标准
- •Any significant acute or chronic medical illness.
- •Any acute infection or febrile illness within 7 days before Day 1 of Cycle
- •Any history or risk for tuberculosis (TB), specifically participants with 1) current clinical, radiographic or laboratory evidence of active TB; 2) history of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; latent TB that has not been successfully treated.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
BMS-986322 and Loestrin
Experimental
Loestrin, then progress to combination
干预措施: BMS-986322 (Drug)
BMS-986322 and Loestrin
Experimental
Loestrin, then progress to combination
干预措施: Loestrin (Drug)
结局指标
主要结局
Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET
时间窗: Up to 28 days
AUC (tau) for EE/NET with BMS-986322
时间窗: Up to 28 days
Maximum observed plasma concentration (Cmax) for EE/NET
时间窗: Up to 28 days
Cmax for EE/NET with BMS-986322
时间窗: Up to 28 days
次要结局
- Number of participants with vital sign abnormalities(Up to 119 days)
- Time of maximum observed plasma concentration (Tmax) for EE/NET(Up to 28 days)
- Number of participants with physical examination abnormalities(Up to 119 days)
- Tmax for BMS-986322(Up to 31 days)
- Cmax for BMS-986322(Up to 31 days)
- AUC (tau) for BMS-986322(Up to 31 days)
- Number of participants with Adverse Events (AEs)(Up to 119 days)
- Number of participants with Serious AEs (SAEs)(Up to 119 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 119 days)
- Tmax for BMS-986322 with EE/NET(Up to 31 days)
- AUC (tau) for BMS-986322 with EE/NET(Up to 31 days)
- Cmax for BMS-986322 with EE/NET(Up to 31 days)
- Number of participants with clinical laboratory abnormalities(Up to 119 days)
- Tmax for EE/NET with BMS-986322(Up to 28 days)
研究者
研究点 (2)
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