A Phase 1 Study to Characterize the Effects of BMS-986166 on the Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone in Healthy Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Geometric means ratio of Cmax of NET
研究概览
简要总结
The purpose of this study is to investigate the potential for a drug-drug interaction (DDI) when BMS-986166 and hormonal oral contraceptives are co-administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 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
- •Nonpregnant, nonlactating Women of Childbearing Potential (WOCBP) who are healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations will be eligible to participate in the study.
- •Body mass index (BMI) of 18.0 to 32.0 kg/m². BMI = weight (kg)/(height[m])² for participants.
- •Participant must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.
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 any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease.
- •Any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986166 + Oral contraceptive
干预措施: BMS-986166 (Drug)
BMS-986166 + Oral contraceptive
干预措施: Oral contraceptive (Drug)
结局指标
主要结局
Geometric means ratio of Cmax of NET
时间窗: Up to Day 26
Geometric means ratio of maximum observed plasma concentration (Cmax) of norethindrone (NET) when administered with versus without BMS-986166
Geometric means ratio of Cmax of EE
时间窗: Up to Day 26
Geometric means ratio of maximum observed plasma concentration (Cmax) of ethinyl estradiol (EE) when administered with versus without BMS-986166
Geometric means ratio of AUC(0-T) of NET
时间窗: Up to Day 26
Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for NET when administered with versus without BMS-986166
Geometric means ratio of AUC(0-T) of EE
时间窗: Up to Day 26
Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for EE when administered with versus without BMS-986166
Geometric means ratio of AUC(INF) of NET
时间窗: Up to Day 26
Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for NET administered with versus without BMS-986166
Geometric means ratio of AUC(INF) of EE
时间窗: Up to Day 26
Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for EE when administered with versus without BMS-986166
次要结局
- Tmax of BMT-121795(Up to Day 26)
- Cmax of BMS-986166(Up to Day 26)
- Cmax of BMT-121795(Up to Day 26)
- Time of maximum observed plasma concentration (Tmax) of BMS-986166(Up to Day 26)
- Area under the plasma concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986166(Up to Day 26)
- AUC(TAU) of BMT-121795(Up to Day 26)
- Tmax of EE(Up to Day 26)
- Tmax of NET(Up to Day 26)
- Terminal plasma elimination phase half-life (T-HALF) of EE(Up to Day 26)
- T-HALF of NET(Up to Day 26)
- Apparent total clearance of drug from plasma after oral administration (CLT/F) of EE(Up to Day 26)
- CLT/F of NET(Up to Day 26)
- Apparent volume of distribution at terminal phase (Vz/F) of EE(Up to Day 26)
- Vz/F of NET(Up to Day 26)
- Number of participants with Adverse Events (AEs)(Up to Day 37)
- Number of participants with Serious Adverse Events (SAEs)(Up to Day 37)
- Number of participants with clinically significant changes in laboratory values: Hematology tests(Up to Day 30)
- Number of participants with clinically significant changes in laboratory values: Chemistry tests(Up to Day 30)
- Number of participants with clinically significant changes in laboratory values: Urinalysis(Up to Day 30)
- Number of participants with clinically significant changes in vital signs: Body temperature(Up to Day 27)
- Number of participants with clinically significant changes in vital signs: Respiratory rate(Up to Day 27)
- Number of participants with clinically significant changes in vital signs: Blood pressure(Up to Day 27)
- Number of participants with clinically significant changes in vital signs: Heart rate(Up to Day 27)
- Number of participants with clinically significant changes in ECG parameters: PR interval(Up to Day 27)
- Number of participants with clinically significant changes in ECG parameters: QRS(Up to Day 27)
- Number of participants with clinically significant changes in ECG parameters: QT interval(Up to Day 27)
- Number of participants with clinically significant changes in ECG parameters: QTcF(Up to Day 27)
- Number of participants with physical examination abnormalities(Up to Day 27)