A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With a Single Dose of Vandetanib (CAPRELSA) 300 mg
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- AUC for digoxin administered alone and in combination with vandetanib 300 mg
研究概览
简要总结
This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin administered alone and in combination with Vandetanib.
详细描述
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination with a Single Dose of Vandetanib (CAPRELSA) 300 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 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 45 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 are current smokers and have smoked or used nicotine products within the previous 6 months
- •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, and human immunodeficiency virus (HIV), or positive screen for drugs of abuse.
研究组 & 干预措施
digoxin then digoxin + vandetanib
Digoxin alone followed by digoxin in combination with vandetanib
干预措施: Digoxin (Drug)
digoxin then digoxin + vandetanib
Digoxin alone followed by digoxin in combination with vandetanib
干预措施: Vandetanib (Drug)
结局指标
主要结局
AUC for digoxin administered alone and in combination with vandetanib 300 mg
时间窗: Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose
Cmax for digoxin administered alone and in combination with vandetanib 300 mg
时间窗: Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose
次要结局
- ECG data(Treatment period + 7-14 days)
- Laboratory data(Treatment period + 7-14 days)
- Vital signs data(Treatment period + 7-14 days)
- Other PK parameters for digoxin administered alone and in combination with vandetanib 300 mg(Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose)
- Digoxin PK parameters for vandetanib in combination with digoxin(Predose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 48, 72, and 96 hrs post dose)
- Frequency and severity of adverse events(Treatment period + 7-14 days)