A Randomized, Open-Label, 2-Way Crossover, Single-Dose Food Effect Study of ZN-c5 in Healthy Adult Post-Menopausal Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
This is a single-center, randomized, open-label, two-period, 2-way crossover food effect study to determine the comparative bioavailability of ZN-c5 under fed and fasting conditions, following single-dose administration of ZN-c5 capsules (150mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers
- •Body mass index (BMI) between > or = 18.0 kg/m2 and < or = 29.9 kg/m2, and a body weight > or = 50kg and < or = 100kg at Screening
- •Non-smoker and must not have used any tobacco products within 2 months prior to Screening, or if a smoker must be currently (and for the last 2 months prior to screening) smoking < or = 2 cigarettes or equivalent per week. Current smokers must be willing to abstain from the use of tobacco and products containing nicotine from 14 days prior to administration of study drug and through the EOS visit.
- •No relevant dietary restrictions, and be willing to consume a high calorie, high fat breakfast and other standard meals provided during the domiciled periods of the study
- •Post-menopausal for > or = 24 months. Status will be confirmed through testing of follicle-stimulating hormone (FSH) levels > or = 40 IU/L at Screening. Participants that are post-menopausal for < or = 24 months are still potentially eligible, but will be required to have a negative serum pregnancy test result at Screening and negative urine pregnancy test result prior to study drug administration.
排除标准
- •Any condition likely to affect the participant's ability to consume the standard meal provided during the domiciled periods of the study, or any condition that may make it difficult for the patient to comply with the requirement for fasting during the study
- •Blood donation or significant blood loss within 60 days prior to the first study drug administration
- •Plasma donation within 7 days prior to the first study drug administration
- •Fever (body temperature > or = 38C) or symptomatic viral or bacterial infection or febrile illness within 2 weeks prior to Screening
- •Positive serum pregnancy test at Screening or urine pregnancy test prior to administration of study drug (for participants who are post-menopausal for < or = 24 months only)
- •Positive toxicology screening panel or alcohol breath test
- •History of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 5 years (by self-declaration)
- •Regular alcohol consumption within the 6 months prior to study drug administration, defined as > 21 alcohol units per week
研究组 & 干预措施
Treatment Sequence A-B
Participants will take ZN-c5 (150mg), single dose, under fasted conditions, and a week later, will take the same drug under fed conditions to determine the comparative bioavailability of ZN-c5 under these conditions.
干预措施: ZN-c5 (Drug)
Treatment Sequence B-A
Participants will take ZN-c5 (150mg), single dose, under fed conditions, and a week later, will take the same drug under fasted conditions to determine the comparative bioavailability of ZN-c5 under these conditions.
干预措施: ZN-c5 (Drug)
结局指标
主要结局
AUC0-t
时间窗: Days 1-4
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time
AUC0-infinity
时间窗: Days 1-4
Area under the plasma concentration-time curve (AUC) from time zero to infinity
Cmax
时间窗: Days 1-4
Maximum concentration
Tmax
时间窗: Days 1-4
Time to maximum concentration
次要结局
- Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs)(Approximately 45 days)