A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination With a Single Dose of 800-mg Vandetanib (CAPRELSA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC for midazolam administered alone and in combination with vandetanib 800 mg
研究概览
简要总结
The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.
详细描述
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination with a Single Dose of 800-mg Vandetanib (CAPRELSA)
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 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, and
- •human immunodeficiency virus (HIV), or
- •Positive screen for drugs of abuse.
研究组 & 干预措施
midazolam then midazolam + vandetanib
Midazolam alone followed by midazolam in combination with vandetanib
干预措施: Midazolam (Drug)
midazolam then midazolam + vandetanib
Midazolam alone followed by midazolam in combination with vandetanib
干预措施: vandetanib (Drug)
结局指标
主要结局
AUC for midazolam administered alone and in combination with vandetanib 800 mg
时间窗: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
Cmax for midazolam administered alone and in combination with vandetanib 800 mg
时间窗: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
次要结局
- Vital signs data(Treatment period from 7 to 14 days)
- Laboratory data(Treatment period from 7 to 14 days)
- Frequency and severity of adverse events(Treatment period from 7 to 14 days)
- ECG data(Treatment period from 7 to 14 days)
- Other PK parameters for midazolam administered alone and in combination with vandetanib 800 mg(Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose)
- Vandetanib PK parameters for vandetanib in combination with midazolam(Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216 hrs post dose)