A Phase 1 Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time to Reach Cmax (Tmax) of EE
研究概览
简要总结
The purpose of this study is to examine the potential for drug-drug interactions.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) within the range of ≥18.5 to ≤30.0 kilograms (kg)/square meter (m^2) at the screening.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and either of the following conditions applies:
- •Is a woman of childbearing potential (WOCBP), having not received any oral contraceptives for at least 28 days prior to the first dose of study intervention, and using a contraceptive method that is highly effective during the treatment period and for at least 14 days after the last dose of study intervention.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.
排除标准
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- •Presence (suspected) or history of having breast cancer, endometrial cancer, or cervical cancer.
- •Presence of unexplained genital bleeding.
- •Participants who have taken injectable or implantable contraceptives, hormonal intrauterine devices, intrauterine hormone-releasing system within 12 months prior to the first dose of study intervention or hormonal contraceptives (intravaginal or transdermal) for 3 months prior to the first dose of study intervention.
- •Participants who are otherwise considered ineligible for the study by the investigator for any other reason.
- •NOTE: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Ensitrelvir
Participants will receive multiple oral doses of a combined oral contraceptive (COC) (EE and DRSP) once daily for 24 days (Days 1 to 24) (in the fasted state on Days 18 to 24) in the morning. Participants will also receive ensitrelvir high dose on Day 20 and multiple oral doses of ensitrelvir low dose once daily on Days 21 to 24 in the fasted state.
干预措施: Ensitrelvir (Drug)
结局指标
主要结局
Time to Reach Cmax (Tmax) of EE
时间窗: Predose and up to 24 hours postdose on Days 19, 20, and 24
Tmax of DRSP
时间窗: Predose and up to 24 hours postdose on Days 19, 20, and 24
AUC0-τ of DRSP
时间窗: Predose and up to 24 hours postdose on Days 19, 20, and 24
Cmax of Drospirenone (DRSP)
时间窗: Predose and up to 24 hours postdose on Days 19, 20, and 24
Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
时间窗: Predose and up to 24 hours postdose on Days 19, 20, and 24
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-τ) of EE
时间窗: Predose and up to 24 hours postdose on Days 19, 20, and 24
次要结局
- Number of Participants With Adverse Events (AEs)(Day 1 up to Day 32)
- Cmax of Ensitrelvir(Predose and up to 24 hours postdose on Days 20 and 24)
- AUC0-τ of Ensitrelvir(Predose and up to 24 hours postdose on Days 20 and 24)
- Tmax of Ensitrelvir(Predose and up to 24 hours postdose on Days 20 and 24)