A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Metformin, an OCT2 Substrate, in Healthy Subjects When Administered Alone and in Combination With a Single Oral Dose of Vandetanib (CAPRELSA) 800 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 metformin administered alone and in combination with vandetanib 800 mg
研究概览
简要总结
Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone and In Combination with Vandetanib
详细描述
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Metformin, an OCT2 Substrate, in Healthy Subjects When administered Alone and in Combination with a Single Oral Dose of Vandetanib (CAPRELSA) 800 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Healthy males or females aged 18 to 50 years with a weight of at least 50 kg and a body mass index between 18 and 30 kg/m2 inclusive.
- •Females must have a negative pregnancy test at screening, must not be lactating and must be of non-childbearing potential.
- •Volunteers will be wild type for the OCT2 gene (as tested for within the last 6 months prior to Day 1 in Period 1)
排除标准
- •History or presence of gastrointestinal, hepatic, or renal disease or any medically significant disorder.
- •History of or ongoing severe allergy/hypersensitivity to drugs with a similar chemical structure or class to vandetanib or metformin.
- •Volunteers who smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center.
- •Known or suspected history of drug abuse.
- •Screening supine blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute.
- •Clinically significant current active skin disease (eg moderate to severe acne, psoriasis, eczema).
- •Any positive result on screening for serum hepatitis B, surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
研究组 & 干预措施
Metformin then metformin + vandetanib
Metformin alone followed by metformin in combination with vandetanib
干预措施: Metformin 1000 mg (Drug)
Metformin then metformin + vandetanib
Metformin alone followed by metformin in combination with vandetanib
干预措施: Vandetanib 800 mg (Drug)
结局指标
主要结局
AUC for metformin administered alone and in combination with vandetanib 800 mg
时间窗: Period 1: Predose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post dose. Period 2: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post-dose.
Cmax for metformin administered alone and in combination with vandetanib 800 mg
时间窗: Period 1: Predose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post dose. Period 2: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post-dose.
次要结局
- Frequency and severity of adverse events(Treatment period 7-14 days)
- Laboratory data(Treatment period 7-14 days)
- Vital signs data(Treatment period 7-14 days)
- PK parameters for metformin in urine when administered alone and in combination with vandetanib(Period 1: Day 1, 0 to 24 hrs and 24 to 48 hrs post metformin dose. Period 2: Day 1, 0 to 24 hrs and 24 to 48 hrs post metformin dose.)
- ECG data(Treatment period 7-14 days)
- Vandetanib PK parameters for vandetanib in combination with metformin(Period 2: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36, 48, 72, 96, 168, 240, 336, 504, and 672 hours post-dose.)
- Other PK parameters for metformin administered alone and in combination with vandetanib 800 mg(Period 1: Predose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post dose. Period 2: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post-dose.)