NCT05891262已完成1 期
A Phase 1, Single-center, Open-label, Single-sequence Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 With Oral Contraceptives in Healthy Female Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年6月6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
- 15
- 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 this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol [EE] and norethindrone [NET]) in healthy female participants.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must be genetically and hormonally female with intact ovarian function by medical history/menstrual cycles.
- •Body mass index between 18.0 and 35.0 kilograms/meter square (kg/m^2), inclusive, at screening.
- •Healthy female participants as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
排除标准
- •Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
- •History of clinically significant heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, clinically significant ECG abnormalities, venous thromboembolism, or any congenital heart disease (as assessed by the investigator).
- •Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect drug absorption, distribution, metabolism and excretion (for example, bariatric procedure).
- •Any major surgery within 4 weeks of study intervention administration, including gastrointestinal surgery that could affect the absorption of study intervention.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
BMS-986196 and Loestrin
Experimental
干预措施: BMS-986196 (Drug)
BMS-986196 and Loestrin
Experimental
干预措施: Loestrin (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
时间窗: At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
时间窗: At Day 1 and Day 20
次要结局
- Number of participants with Serious AEs (SAEs)(Up to Day 49)
- Time of maximum observed plasma concentration (Tmax)(At Day 1 and Day 20)
- Terminal half-life (T-HALF)(At Day 1 and Day 20)
- Apparent total body clearance (CLT/F)(At Day 1 and Day 20)
- Number of participants with Adverse Events (AEs)(Up to Day 49)
- Number of participants with clinical laboratory abnormalities(Up to Day 49)
- Number of participants with vital sign abnormalities(Up to Day 49)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 49)
- Number of participants with physical examination abnormalities(Up to Day 49)
- Number of participants with any abnormal columbia-suicide severity rating scale (C-SSRS)(Up to Day 49)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Drug Interaction Study With RosuvastatinImmunosuppression For DiseaseNCT02101125Bristol-Myers Squibb26
终止
1 期
An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be RemovedAdvanced CancerNCT03444753Bristol-Myers Squibb82
进行中（未招募）
3 期
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate CancerMetastatic Castration-resistant Prostate CancerNCT06764485Celgene960
撤回
1 期
A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult ParticipantsHealthy Adult VolunteersNCT06034899Bristol-Myers Squibb
已完成
2 期
A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT05005273Bristol-Myers Squibb1