Open Label, Randomized, Cross-over Study to Explore the Pharmacokinetics of BAY1834845 After Oral and Intravenous Dosing, Including Food Effect and Absolute Bioavailability (Part A), and to Investigate the Effect of BAY1834845 on the Pharmacokinetics of Orally Administered Methotrexate (Part B) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- AUC (Area under the concentration-versus-time curve from zero to infinity after single (first) dose) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
研究概览
简要总结
This study is planned to explore the effect of food on the oral pharmacokinetics, the intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore, this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male; healthy according to complete medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests as listed in the exclusion criteria given below.
- •Age 18-50 years (inclusive) at the first screening visit.
- •Body mass index: >=18 kg/m² and <=30 kg/m².
- •Sexually active men must agree to practice adequate methods of contraception (protection).
- •This applies for the time period between signing of the informed consent form and up to 90 days after the last administration of the study drug(s).
排除标准
- •Any contraindications for intake of BAY 1834845 or methotrexate, gastrointestinal, liver, renal, lung or cardiovascular disorders, malignant tumors, known severe allergies, known or suspected immunodeficiency
- •Medication history: drugs known to induce/inhibit liver enzymes
- •Clinically relevant findings in
- •ECG, blood pressure
- •laboratory values
- •Known hypersensitivity to study drug(s)
研究组 & 干预措施
Oral Methotrexate + oral BAY1834845
Study part B, cross over sequence:
- single oral dose of methotrexate (MTX) + single oral dose of BAY1834845
- single oral dose of MTX
干预措施: BAY1834845 (Drug)
Oral BAY1834845
Study Part A, cross over sequence:
- single oral dose of BAY1834845
- single oral dose of BAY1834845 + i.v. BAY1834845
- single oral dose of BAY1834845 under fed conditions
干预措施: BAY1834845 (Drug)
Oral BAY1834845 + i.v. BAY1834845
Study Part A, cross over sequence:
- single oral dose of BAY1834845+ i.v. BAY1834845
- single oral dose of BAY1834845
- single oral dose of BAY1834845 under fed conditions
干预措施: BAY1834845 (Drug)
Oral Methotrexate
Study part B, cross over sequence:
- single oral dose of methotrexate (MTX)
- single oral dose of MTX + single oral dose of BAY1834845
干预措施: BAY1834845 (Drug)
Oral Methotrexate
Study part B, cross over sequence:
- single oral dose of methotrexate (MTX)
- single oral dose of MTX + single oral dose of BAY1834845
干预措施: Methotrexate (Drug)
Oral Methotrexate + oral BAY1834845
Study part B, cross over sequence:
- single oral dose of methotrexate (MTX) + single oral dose of BAY1834845
- single oral dose of MTX
干预措施: Methotrexate (Drug)
结局指标
主要结局
AUC (Area under the concentration-versus-time curve from zero to infinity after single (first) dose) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
时间窗: Multiple timepoints up to day 7
in study part A
Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
时间窗: Multiple timepoints up to day 7
in study part A
Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration
时间窗: Multiple timepoints up to day 7
in study part A
Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration
时间窗: Multiple timepoints up to day 7
in study part A
Absolute oral bioavailability (F) of BAY1834845 in the fasted state
时间窗: Multiple timepoints up to day 7
in study part A
AUC of methotrexate in plasma in presence/absence of BAY1834845
时间窗: Multiple timepoints up to day 2
in study part B
Cmax of methotrexate in plasma in presence/absence of BAY1834845
时间窗: Multiple timepoints up to day 2
in study part B
次要结局
- Frequency of TEAEs in part B(Up to 6 weeks)
- Severity of TEAEs in part A(Up to 9 weeks)
- Frequency of Treatment Emergent Adverse Events (TEAEs) in part A(Up to 9 weeks)
- Severity of TEAEs in part B(Up to 6 weeks)