Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter AUC TAU
研究概览
简要总结
This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female nonsmoking subjects, ages 18 to 40 years, inclusive with a body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive
- •Women of child bearing potential with intact ovarian function by medical history and history of regular menstrual cycles must have been on a stable regimen of combination oral contraceptives containing EE and progestin (28 day regimen) without evidence of breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1
排除标准
- •Any significant acute or chronic medical illness
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
Single Sequence A, B, C, and D
Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth.
干预措施: BMS-663068 (Drug)
Single Sequence A, B, C, and D
Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth.
干预措施: Oral Contraceptive (Drug)
Single Sequence A, B, C, and D
Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth.
干预措施: Loestrin 1.5/30 (Drug)
结局指标
主要结局
Pharmacokinetic parameter AUC TAU
时间窗: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Pharmacokinetic parameter includes: area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE.
Pharmacokinetic parameter Cmax
时间窗: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Pharmacokinetic parameter includes: maximal observed concentration (Cmax) for EE and NE.
次要结局
- Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).(From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4))
- Clinical Safety as measured by Physical Examination.(From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4))
- Clinical Safety as Measured by Adverse Event Monitoring.(From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4))
- Pharmacokinetic Parameter(From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4)
- Clinical Safety as Measured by the Collection of Vital Signs.(From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4))
- Clinical Safety as Measured by Clinical Laboratory Evaluations.(From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4))