A Study to Assess the Effects of Single Oral Doses of MK-8527 on the Single-Dose Pharmacokinetics of an Oral Contraceptive (Levonorgestrel and Ethinyl Estradiol) in Healthy Adult Postmenopausal or Oophorectomized Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527
研究概览
简要总结
This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •is in good overall health
- •assigned female at birth
排除标准
- •has a history of clinically significant endocrine, GI, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
- •has a history of cancer (malignancy)
研究组 & 干预措施
Arm 1: All Participants
Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527.
干预措施: MK-8527 (Drug)
Arm 1: All Participants
Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527.
干预措施: LNG/EE (Drug)
结局指标
主要结局
Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527
时间窗: Up to ~96 hours postdose
Maximum plasma concentration (Cmax) of LNG alone and with MK-8527
时间窗: Up to ~96 hours postdose
Time to Cmax (Tmax) of LNG alone and with MK-8527
时间窗: Up to ~96 hours postdose
Apparent half-life (t½) of LNG alone and with MK-8527
时间窗: Up to ~96 hours postdose
AUC0-∞ of EE alone and with MK-8527
时间窗: Up to ~72 hours postdose
Tmax of EE alone and with MK-8527
时间窗: Up to ~72 hours postdose
次要结局
- Percentage of participants with ≥1 adverse event (AE)(Up to ~28 days)
- Percentage of participants discontinuing from study therapy due to AE(Up to ~28 days)