A Two-part, Crossover Study to Investigate the Effects of Morning Versus Evening Dosing and Food Interaction on the Pharmacodynamics and Pharmacokinetics of Single and Multiple Doses of ONO-5334 in Healthy Post Menopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Part 2: Compare the effects of food on the pharmacodynamics (i.e., AUC, Cmax) of a single dose of ONO-5334
研究概览
简要总结
The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal women.
详细描述
This study consists of 2 parts. Part 1; The study will investigate the effects of morning versus evening dosing on the pharmacodynamics of multiple doses of 150 mg of ONO-5334 in healthy post menopausal women. The study design will be single-blind and 16 subjects will be enrolled. Part 2; The study will investigate the effects of food on the pharmacokinetics of a single dose of 150mg of ONO-5334 in healthy post menopausal women. 12 subjects will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy caucasian women aged between 55 to 75 years inclusive
- •Subjects weighing at least 50 kg with mass index between 19 to 30 kg/m2 inclusive
- •Subjects who have been amenorrhoeic for at least 5 years.
- •Subjects who are confirmed at Screening Visit to have oestradiol and follicle stimulating hormone (FSH) levels consistent with menopause
排除标准
- •Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
- •Subjects who have a clinically relevant history of insomnia or sleep disorders
研究组 & 干预措施
E1
ONO-5334
干预措施: ONO-5334 (Drug)
E2
ONO-5334
干预措施: ONO-5334 (Drug)
结局指标
主要结局
Part 2: Compare the effects of food on the pharmacodynamics (i.e., AUC, Cmax) of a single dose of ONO-5334
时间窗: end of day 1
Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334
时间窗: end of treatment (5 days)
次要结局
- Safety and tolerability of single or multiple dose of ONO-5334 in healthy post menopausal women(up to the day after the last dose (Part 1: 5 day multiple doses; Part 2: single dose))