NCT01414881已完成1 期
A Phase 1 Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
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
- 20
- 试验地点
- 1
- 主要终点
- Percent change in the production rate (PR) of very low density lipoprotein (VLDL) apolipoprotein B (apo B)
研究概览
简要总结
The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period, a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment Period with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total duration of any given subject's participation will be approximately 40 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- Single (Participant)
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
- •Non-pregnant, non-lactating, surgically sterile, postmenopausal, abstinent, or the subject or partner is compliant with an acceptable contraceptive regimen for 4 weeks prior to Screening and willing to remain compliant with the contraceptive regimen throughout treatment and for 25 weeks after the last investigational product dose
- •Body weight >50 kg, body mass index (BMI) ≤38 kg/m2, and stable weight (i.e., within 5% of mean body weight) for > 8 weeks prior to Screening
- •Fasting TG levels of ≤170 mg/dL, fasting serum blood glucose of ≤115 mg/dL, and an HbA1c ≤6.5%
排除标准
- •Presence of any clinically significant abnormal laboratory profiles, physical exams, vital signs, or ECGs
- •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease
- •Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for >1 year) at Screening
- •History of relevant food and/or drug allergies (i.e., allergy to heparin or any significant food allergy that could preclude a stable diet)
- •The subject is receiving prescription lipid-lowering therapies such as statins, bile acid sequestrants, niacin/nicotinic acid, and/or fibrates or over-the-counter (OTC) fish oils, flaxseed, red rice or nutrient supplements that might affect lipid levels
- •The subject is unwilling to limit alcohol consumption for the entire duration of the study
- •The subject smokes >5 cigarettes per day
研究组 & 干预措施
mipomersen
Experimental
mipomersen 200mg subcutaneously (SC) once weekly
干预措施: mipomersen (Drug)
Placebo
Placebo Comparator
Placebo administered subcutaneously (SC) once weekly
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in the production rate (PR) of very low density lipoprotein (VLDL) apolipoprotein B (apo B)
时间窗: through approximately 11 weeks of treatment
次要结局
- Conversion of VLDL apo B to low-density lipoprotein (LDL) apo B(Through approximately 11 weeks of treatment)
- Post-heparin hepatic lipase and lipoprotein lipase activities in serum(Through approximately 11 weeks of treatment)
- Fasting plasma levels of fatty acids and beta-hydroxybutyrate(Up to 40 weeks)
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(Up to 40 weeks)
- Fractional clearance rate (FCR) of VLDL Triglyceride (TG), VLDL apo B, intermediate density lipoprotein (IDL) apo B, and low-density lipoprotein (LDL) apo B(Through approximately 11 weeks of treatment)
- Production rate (PR) of VLDL-TG, IDL apo B, LDL apo B(Through approximately 11 weeks of treatment)
- Direct removal of VLDL apo B from plasma(Through approximately 11 weeks of treatment)
研究者
研究点 (1)
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