Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (10 - 1500 mg, Tablets) of BAY1817080 Including the Effect of Food and Itraconazole on the Relative Bioavailability of BAY1817080 in Healthy Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Frequency of treatment-emergent adverse events
研究概览
简要总结
This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 will be investigated.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Age: 18 to 45 years (inclusive)
- •Body mass index (BMI) : ≥18 and ≤30 kg/m²
- •Race: White
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Relevant diseases within the last 4 weeks prior to the first drug administration
- •Existing chronic diseases requiring medication
- •Known or suspected malignant tumors or carcinoma in situ (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial until follow-up including drugs which might affect the pharmacokinetics
研究组 & 干预措施
BAY1817080
Study Part 1: Dose 1 to 7 of BAY1817080 (increasing dose levels; redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food [American breakfast]); Study part 2: Dose 1 to 4 of BAY1817080 together with an American breakfast (increasing dose levels; redosing of BAY1817080 at dose group 1, 2 and 4 together with food [Continental breakfast])
干预措施: BAY1817080 (Drug)
BAY1817080
Study Part 1: Dose 1 to 7 of BAY1817080 (increasing dose levels; redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food [American breakfast]); Study part 2: Dose 1 to 4 of BAY1817080 together with an American breakfast (increasing dose levels; redosing of BAY1817080 at dose group 1, 2 and 4 together with food [Continental breakfast])
干预措施: Itraconazole (Drug)
Placebo
Study Part 1: Placebo Dose 1 to 7 of BAY1817080; Study Part 2: Placebo Dose 1 to 4 of BAY1817080
干预措施: Placebo (Drug)
Placebo
Study Part 1: Placebo Dose 1 to 7 of BAY1817080; Study Part 2: Placebo Dose 1 to 4 of BAY1817080
干预措施: Itraconazole (Drug)
结局指标
主要结局
Frequency of treatment-emergent adverse events
时间窗: Up to 4 months
Severity of treatment-emergent adverse events
时间窗: Up to 4 months
次要结局
未报告次要终点