An Open-label, Single Group Study to Evaluate the Effect of Repeated Oral Administration of Itraconazole (ITZ) on the Single Oral Dose Pharmacokinetics of BAY1902607 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Cmax of BAY1902607
研究概览
简要总结
BAY1902607 is a new type of drug under clinical development for different conditions including the treatment of endometriosis, i.e. a condition where the tissue that usually grows inside the womb grows outside of the womb.
Itraconazole (ITZ) is an approved drug often used for the treatment of fungal infections and possibly inhibits the breakdown of BAY1902607. In this clinical study, BAY1902607 is given alone by mouth or in combination with ITZ. Researchers want to learn more how quickly and to what extent the study drug BAY1902607 given by mouth to healthy male participants is absorbed by the human body, reaches the blood stream and is excreted again. In addition they want to find out whether the elimination of the study drug BAY1902607 is influenced by ITZ given at the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, male adults
- •Body mass index ≥ 18 and ≤ 30.0 kg/m²
- •Body weight ≥ 50 kg
排除标准
- •Known or suspected allergy or hypersensitivity to BAY1902607, itraconazole or any of their excipients
- •Contraindications to itraconazole (symptoms or history of ventricular dysfunction, heart failure, liver disease).
- •Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 1 week prior to the first drug administration or during the trial until follow-up (occasional use of ibuprofen is permissible). Particularly, this includes drugs that might affect the pharmacokinetics (PK) of BAY1902607, e.g. laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists, CYP3A4 inhibitors or inducers.
研究组 & 干预措施
Healthy men
Healthy male adults from Germany receiving BAY1902607 during study period 1 (length = 6 days) and BAY1902607 + Itraconazole during study period 2 (length = 15 days), separated by a washout phase.
干预措施: BAY1902607 (Drug)
Healthy men
Healthy male adults from Germany receiving BAY1902607 during study period 1 (length = 6 days) and BAY1902607 + Itraconazole during study period 2 (length = 15 days), separated by a washout phase.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Cmax of BAY1902607
时间窗: -0.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 96 hours after drug
Maximum concentration of BAY1902607 in blood
Cmax of BAY1902607 with itraconazole
时间窗: -1.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours after BAY1902607
Maximum concentration of BAY1902607 in blood with concomitant administration of itraconazole
AUC of BAY1902607
时间窗: -0.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 96 hours after drug
Area under the concentration versus time curve of BAY1902607 (time from 0 to 96 hours) after single dose
AUC of BAY1902607 with itraconazole
时间窗: -1.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours after BAY1902607
Area under the concentration versus time curve (time from 0 to 264 hours) after single dose of BAY1902607 and concomitant administration of itraconazole
次要结局
未报告次要终点