NCT02229773已完成1 期
Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability After Multiple Oral Doses of 0.25 mg, 0.5 mg and 1 mg o.d. BIBB 1464 (Tablet) or Pravastatin 20 mg Over 2 Weeks in Hyperlipemic Healthy Male Subjects (Parallel Group Comparison, Randomized, Placebo Controlled, Partly Double Blind [Pravastatin Open])
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Percentage change of total plasma cholesterol
研究概览
简要总结
Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary pharmacokinetics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male Caucasian subjects as determined by results of screening
- •Written informed consent in accordance with GCP and local legislation given
- •Age >= 18 and <= 65 years
- •Broca >= - 20% and <= + 30%
- •LDL-cholesterol level >= 3.3 mmol/L at pre-screening and at the two screening visits
排除标准
- •Any finding of the medical examination. (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
- •Surgery of the gastro-intestinal tract (except appendectomy)
- •Disease of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History or orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged the investigator
- •Intake of drugs with a long half-life (> 24 hours) (<= 1 month prior to administration or during the trial)
- •Use of any drugs which might influence the result of the trial (<= 10 days prior to administration or during the trial)
- •Participation in another trial with an investigational drug (<= 2 month prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars or >3 pipes/day)
- •Inability to refrain from smoking during the period of the study
- •Alcohol abuse (>60/g/day)
- •Drug abuse
- •Blood donation (>400ml <=1 month prior to administration)
- •Excessive physical activities (<=5 days prior to administration)
- •Any laboratory value outside the normal range of clinical relevance
- •LDL - cholesterol screening measurements day -1 and day -7 the different between these two values exceed 12% of the higher dose
- •subjects who are vegetarian
- •Cataract extraction in one or both eyes deemed likely within 2 years ("senile", non-idiopathic will not automatically exclude patients from participation)
- •Lens Opacities Classification System (LOCS) III grade >3.0 (for nuclear opalescence or cortical grad) >0.5 (for posterior sub capsular grad)
- •Log MAR Bailey-Lovie visual acuity >0.5
- •Corneal or conjunctival problems which would preclude lens photography
- •Shallow anterior chamber with risk of angle-closure glaucoma
- •Pupil will not dilate to at least 6 mm
- •Visually significant fundus pathology in clinician's judgment
- •Amblyopia, optic nerve disease, iritis, history of eye surgery, argon or YAG laser, major eye trauma, extended use (daily for >3 month) of ocular or systemic corticosteroid treatment , use of anticoagulants, or glaucoma therapy, or participation in another clinical trial investigation an anti-cataract or cataractogenic formulation within the last year
研究组 & 干预措施
BIBB 1464 MS low dose
Experimental
干预措施: BIBB 1464 MS low dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Pravastatin
Active Comparator
干预措施: Pravastatin (Drug)
BIBB 1464 MS medium dose
Experimental
干预措施: BIBB 1464 MS medium dose (Drug)
BIBB 1464 MS high dose
Experimental
干预措施: BIBB 1464 MS high dose (Drug)
结局指标
主要结局
Percentage change of total plasma cholesterol
时间窗: baseline, 2 weeks
Percentage change of LDL plasma cholesterol
时间窗: baseline, 2 weeks
次要结局
- Number of patients with clinical significant findings in vital signs(Up to day 15)
- Number of patients with clinical significant findings in physical examination(Up to day 28)
- Investigator assessed tolerability on a 4 point scale(day 42)
- Percentage change in lipid profile(baseline, 1 week)
- Number of patients with clinical significant findings in eye lens opacification(Up to day 42)
- Number of patients with clinical significant findings in laboratory parameters(Up to day 28)
- Number of patients with adverse events(Up to day 42)
- Number of patients with clinical significant findings in electrocardiogram (ECG)(Up to day 28)
- Monoepoxysqualene (MES) plasma concentration(Up to day 28)
- Amount of drug excreted in urine(Up to day 15)
- Drug plasma concentration(Up to day 28)
研究者
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