A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 主要终点
- Pharmacokinetic parameters: Cmax
研究概览
简要总结
Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food.
详细描述
Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food, with a 10 Day washout period between treatments. There will be 8 treatment sequences with 4 subjects randomized to each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to follow verbal and written instructions
- •Informed consent form signed by the subject
- •Completed screening within 7 days prior to dosing
- •BMI between 18.5 and 35 kg/m2
- •Generally healthy
- •fasting glucose less than or equal to 100 mg/dL
- •HbA1c less than or equal to 6%
排除标准
- •Pregnancy or breast feeding
- •absence of contraception
- •administration of investigational drug within 1 month prior to screening
- •anticipated requirement for prohibited medication (systemic corticosteroids or anti-diabetic medications)
- •allergic reaction to or significant intolerance of diazoxide, thiazides or sulfonamides
- •known type 1 or type 2 diabetes mellitus
- •congestive heart failure
- •gastric bypass surgery
- •history of drug or alcohol abuse
研究组 & 干预措施
DCCR 75 mg fasted
Administered a single 75 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
干预措施: Diazoxide choline controlled-release tablet (Drug)
DCCR 150 mg fasted
Administered a single 150 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
干预措施: Diazoxide choline controlled-release tablet (Drug)
DCCR 300 mg fasted
Administered a single 300 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
干预措施: Diazoxide choline controlled-release tablet (Drug)
DCCR 450 mg fasted
Administered a single 450 mg dose of DCCR after an overnight fast followed by 4 hours of fasting
干预措施: Diazoxide choline controlled-release tablet (Drug)
DCCR 300 mg fed
Administered a single 300 mg dose of DCCR after a standardized meal
干预措施: Diazoxide choline controlled-release tablet (Drug)
结局指标
主要结局
Pharmacokinetic parameters: Cmax
时间窗: up to 24 hours
Cmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose
Pharmacokinetic parameters: AUC0-24
时间窗: up to 24 hours
AUC0-24 derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours
次要结局
- Pharmacokinetic parameters: CL/F(up to 24 hours)
- Pharmacokinetic parameters: Tmax(up to 24 hours)