Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 51
- 主要终点
- Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading
研究概览
简要总结
The objective of this trial is to investigate the safety and tolerability of BAY1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route. The investigational substance will be administered in tablet form to healthy women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal state, revealed by
- •Medical history. One of the following:
- •Natural menopause at least 12 months prior to first study drug administration,
- •Surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration) or
- •Hysterectomy AND
- •Follicle-stimulating hormone (FSH) > 40 IU/L
- •Age 45 to 68 years
- •Healthy female subjects
- •Sterilized by tubal-ligation
- •Pre-treatment menstrual cycle assessed as ovulatory
- •Completion of more than 3 menstrual cycles after delivery, abortion or lactation
- •Age 18 to 48 years
排除标准
- •Body mass index (kg/m2) greater or equal 32 (or less or equal 18)
- •Smoking: PART A: non-smoking; PART B: less than 10 cigarettes per day
- •Use of medicines including but not restricted to contraceptives and NSAIDs (details regarding previous use of medicines provided by the study center)
- •Ability and willingness to adhere to restrictions regarding diet (PART A and B) and to eat standardised meals (PART A only)
- •Significant diseases of the heart, gastrointestinal tract and/or liver and/or kidney and/or reproductive organs (present or in the past; details will be provided by the study center)
- •Recent infectious diseases (details will be provided by the study center)
- •Migraine or depression
- •Thyroid disease which requires treatment
- •Metabolic disorders, for example diabetes mellitus or hypertriglyceridemia
- •Drug or alcohol abuse; regular consumption of more than 800 ml of beer per day (or other drinks resembling 40 g of alcohol)
研究组 & 干预措施
BAY1128688 [Dose3]
BAY1128688 dose level 3
干预措施: BAY1128688 (Drug)
BAY1128688 [Dose1]
BAY1128688 dose level 1
干预措施: BAY1128688 (Drug)
BAY1128688 [Dose2]
BAY1128688 dose level 2
干预措施: BAY1128688 (Drug)
BAY1128688 [Dose4]
BAY1128688 dose level 4
干预措施: BAY1128688 (Drug)
Placebo
Placebo to match arm 1,2, 3 and 4
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading
时间窗: Up to 2 months
Cmax,md (maximum concentration) of BAY1128688 after multiple dose
时间窗: 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
Cav,md (average steady state concentration) of BAY1128688 after multiple dose
时间窗: 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
次要结局
未报告次要终点