A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects When a Single Oral Dose of Vandetanib 300 mg is Administered Alone and in Combination With Omeprazole or Ranitidine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Cmax for a single dose of vandetanib alone and in combination with omeprazole (PPI)
研究概览
简要总结
Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib
详细描述
A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects when a Single Oral Dose of Vandetanib 300 mg is Administered Alone and in Combination with Omeprazole or Ranitidine
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study-specific procedures
- •Volunteers must be males or females aged 18 to 50 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2
- •Inclusive Females must have a negative pregnancy test at screening and on admission to the study center
- •Females must not be lactating and must be of non childbearing potential defined as postmenopausal or documentation of irreversible surgical sterilization.
排除标准
- •History of any clinically significant disease or disorder such as gastrointestinal, hepatic, renal or skin disease.
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
- •Volunteers who smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center
- •Screening blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute (repeat test allowed at the Investigator's discretion
- •Clinically significant abnormal12-lead ECG as assessed by the Investigator
- •QTcF interval greater than 450 ms Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody
- •Human immunodeficiency virus (HIV), or positive screen for drugs of abuse.
研究组 & 干预措施
vandetanib then vandetanib + omeprazole
Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2
干预措施: vandetanib (Drug)
vandetanib then vandetanib + omeprazole
Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2
干预措施: omeprazole (Drug)
vandetanib + omeprazole then vandetanib
Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2
干预措施: vandetanib (Drug)
vandetanib + omeprazole then vandetanib
Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2
干预措施: omeprazole (Drug)
vandetanib then vandetanib + ranitidine
Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2
干预措施: vandetanib (Drug)
vandetanib then vandetanib + ranitidine
Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2
干预措施: ranitidine (Drug)
vandetanib + ranitidine then vandetanib
Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2
干预措施: vandetanib (Drug)
vandetanib + ranitidine then vandetanib
Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2
干预措施: ranitidine (Drug)
结局指标
主要结局
Cmax for a single dose of vandetanib alone and in combination with omeprazole (PPI)
时间窗: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
AUC(0-t) for a single dose of vandetanib alone and in combination with omeprazole (PPI)
时间窗: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Cmax for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
时间窗: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
AUC(0-t) for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
时间窗: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
次要结局
- Other PK parameters for a single dose of vandetanib alone and in combination with omeprazole (PPI)(Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose)
- Other PK parameters for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)(Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose)
- Frequency and severity of adverse events(Treatment period + 7-14 days)
- ECG data(Treatment period + 7-14 days)
- Laboratory data(Treatment period + 7-14 days)
- Vital signs data(Treatment period + 7-14 days)