NCT00709553已完成1 期
A Randomised, Open-label, Crossover, Phase I Study to Assess the Effect of Multiple Oral Doses of ZD4054 (Zibotentan) on the Pharmacokinetics of a CYP450 3A Probe (Midazolam) in 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
- 12
- 试验地点
- 1
- 主要终点
- PK variables
研究概览
简要总结
The purpose of the study is to to assess the effect of multiple oral doses of ZD4054 (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 18 and 30 kg/m2
- •Medical and surgical history and physical examination without any clinically significant findings
- •Normal resting ECG with QTcB interval <450ms
排除标准
- •Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
- •Healthy volunteer has a known hypersensitivity to midazolam or any of the excipients of the midazolam tablet
- •Medical diagnosis of migraine with an attack during the 12 months prior to Screening
研究组 & 干预措施
1
Experimental
midazolam, one single dose of 705mg
干预措施: midazolam (Drug)
2
Experimental
ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 )
干预措施: midazolam (Drug)
2
Experimental
ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 )
干预措施: ZD4054 (Drug)
结局指标
主要结局
PK variables
时间窗: Frequent sampling occasions during study
次要结局
- Safety variables (adverse events, ECG, blood pressure, pulse, safety lab)(During the whole treatment period)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate CancerMetastases, NeoplasmProstatic NeoplasmsNCT00055471AstraZeneca22
已完成
1 期
Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets.HealthyNCT00713791AstraZeneca20
已完成
1 期
Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc IntervalHealthyNCT00713336AstraZeneca40
已完成
1 期
Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPCProstate CancerNCT00314782AstraZeneca44
已完成
2 期
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)Prostate CancerNCT00090363AstraZeneca447