NCT01211860已完成1 期
A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Steady-state Pharmacokinetic profile of DCCR
研究概览
简要总结
Once a day oral administration with DCCR is the optimal dosing regimen
详细描述
POPULATION The population will consist of generally healthy subjects with elevated fasting triglyceride levels in the range of ≥ 150 mg/dL and ≤ 1500 mg/dL at the Screening Visit.
Number of Subjects A total of 10 subjects will be enrolled in the study at 1 site in the USA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Basic requirements
- •Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing
- •Body mass index (BMI) between 22 and 35 kg/m2
- •Specific laboratory test results
- •Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL
- •Fasting glucose ≤ 110 mg/dL
- •HbA1c ≤ 6.0 %
排除标准
- •Medications: recent, current, anticipated
- •Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
- •Thiazide diuretics within 2 weeks prior to Screening Visit
- •History of allergic reaction or significant intolerance to:
- •Sulfonamides
- •Lifestyle changes
- •Subjects intending to change exercise habits, and/or quit smoking
- •Specific diagnoses, medical conditions and history
- •Known type I or III hyperlipidemia
- •Known type 1 DM
- •Known type 2 DM
- •Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the Investigator
- •Specific laboratory test results
- •Any relevant biochemical abnormality interfering with the assessments of the investigational drug
研究组 & 干预措施
DCCR Treatment
Experimental
DCCR Treatment 290 mg diazoxide choline
干预措施: Diazoxide Choline Controlled-Release Tablet (Drug)
结局指标
主要结局
Steady-state Pharmacokinetic profile of DCCR
时间窗: 10 days
* Mean concentration-time profile for diazoxide * Steady-state pharmacokinetic parameters of diazoxide (Cmax(ss), AUC0-inf(ss), and CL/F) * Terminal elimination half-life (t½) of diazoxide
次要结局
- Concentration-Time profile of major metabolite(10 days)
研究者
研究点 (1)
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