NCT00812344已完成1 期
An Open, Randomised, Cross-over, Single Centre Pharmacokinetic (Phase I) Study of the Biliary Excretion Following Single Doses of AZD0837, Given in the Duodenum Via a Loc-I-Gut Catheter, Alone or in Combination With Ketoconazole (Once Daily for 4 Days), to Young Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX.
研究概览
简要总结
This is an explorative study and the scientific question to be investigated is if the biliary excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by co-administration with ketoconazole
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
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
- •body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive
排除标准
- •Significant illness, trauma or surgical procedures.
- •Clinically significant laboratory abnormalities.
- •Clinically significant medical history
研究组 & 干预措施
1
Experimental
干预措施: AZD0837 (Drug)
2
Active Comparator
AZD0837 + Ketoconazole
干预措施: AZD0837 (Drug)
2
Active Comparator
AZD0837 + Ketoconazole
干预措施: ketoconazole (Drug)
结局指标
主要结局
Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX.
时间窗: Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.
次要结局
- PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.(Frequent sampling during 24 hours.)
- Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography.(Some of the safety variables will be followed at each visit, some less frequent.)
- Pharmacogenetics(One sampling during the study.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies)Solid TumorsNCT02828930Hoffmann-La Roche8
已完成
1 期
A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male VolunteersHealthy VolunteerNCT01592890Hoffmann-La Roche6
招募中
Unknown
A prospective observational study on biliary tract cancer cases undergoing the cancer multi-gene panel testingbiliary tract cancerJPRN-UMIN000049162Tohoku University Graduate School of Medicine, Department of Surgery1,000
已完成
1 期
A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male ParticipantsHealthyNCT03036501Hoffmann-La Roche6
已完成
不适用
Prospective Evaluation of Biliary Tissue Sampling With ERCPCholangiopancreatography, Endoscopic RetrogradeBiliary StrictureBiliary Tract DiseasesCholangiocarcinomaNCT04572711Mayo Clinic327