Randomized, Double-blind, Placebo-controlled, Escalating Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered BAY1161116 in Healthy Postmenopausal Women Including Food-effect and Drug-drug-interaction With Itraconazole
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of TEAEs
研究概览
简要总结
This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female postmenopausal subjects
- •Age: 45 to 65 years (inclusive)
- •Body mass index (BMI) : ≥18 and ≤30 kg/m²
- •Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)
排除标准
- •Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion,and effect of the study drugs will not be normal
- •Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (occasional use of paracetamol or ibuprofen is permissible)
- •Any severe disease within the last 4 weeks prior to the first study drug administration
- •History of orthostatic hypotension, fainting spells, blackouts
- •Any malignant tumor and history thereof
- •Any other medical condition which, at the discretion of the investigator, would make study participation unadvisable
- •Any clinically relevant finding at the physical- and gynecological examinations
- •Allergy, hypersensitivity, or non-allergic drug reactions to any excipient of the IMP or reference/interaction product
- •Regular alcohol consumption equivalent to >20 g alcohol per day
- •Urine screen positive for any drug or cotinine
研究组 & 干预措施
BAY1161116
Dose steps 1 to 6 of BAY1161116 (increasing dose levels)
干预措施: BAY1161116 (Drug)
BAY1161116
Dose steps 1 to 6 of BAY1161116 (increasing dose levels)
干预措施: Itraconazole (Drug)
Placebo
Placebo Dose 1 to 6 of BAY 1161116
干预措施: Placebo (Drug)
Placebo
Placebo Dose 1 to 6 of BAY 1161116
干预措施: Itraconazole (Drug)
结局指标
主要结局
Incidence of TEAEs
时间窗: 5 weeks
TEAEs: treatment-emergent adverse events
Severity of TEAEs
时间窗: 5 weeks
TEAEs: treatment-emergent adverse events
AUC of BAY1161116
时间窗: 5 weeks
AUC: Area under the concentration vs. time curve from zero to infinity
Cmax of BAY1161116
时间窗: 5 weeks
Cmax: maximum observed drug concentration
次要结局
未报告次要终点