NCT00428415已完成1 期
The Effect of Tesofensine on Energy Balance in Humans. A Randomised, Double-Blind, Placebo-Controlled, Parallel- Group, Single Centre Study.
NeuroSearch A/S2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2007年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Effect on 24-h EE (energy expenditure) after 14 days dosing, adjusted for FFM(Fat-Free Mass) and FM (Fat Mass) changes
研究概览
简要总结
Purpose:
To evaluate the effect of tesofensine on energy balance
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Overweight to obese subjects with BMI 28 - 35 kg/m² otherwise healthy
- •Males 18 to 50 years of age, extremes included
- •Subjects should be able to comply with study procedures
- •Subjects giving written informed consent
排除标准
- •Use of any concomitant medication including high dose vitamins and regular OTC preparations
- •Subjects who have been smokers within the last year
- •Subjects with specific diseases interfering with their metabolism e.g. myxoedema, Cushing's syndrome, Type 1 diabetes mellitus, significant neurological or psychiatric illness such as epilepsy, schizophrenia, depression, eating disorders such as bulimia.
- •Subjects with Type 2 diabetes mellitus are ineligible unless anti-diabetic medication was not deemed necessary by the investigator and fasting (venous or arterialized capillary full blood from finger or ear) blood glucose > 6.1 mmol/l at screening. Re-test is allowed if first measure is above inclusion value. The corresponding exclusion criteria for plasma glucose is 7.0 mmol/l
- •Known hypercholesterolaemia (> 7 mmol/l).
- •Known hypertriglyceridaemia (> 3 mmol/l).
- •Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine
- •Mental or psychiatric disorder based on medical history only
- •Subjects with systemic infections or inflammatory diseases
- •Subjects currently (within the past 2 months) known to abuse or to be dependent on any drug, including alcohol (weekly consumption > 21 units of alcohol )
- •Hepatic or renal dysfunction (ASAT and/or ALAT > 2 x ULN and creatinine clearance < 30 mL/min estimated by central laboratory using Cockcroft and Gault formula, respectively)
- •Special diets (e.g., vegetarian, Atkins)
- •Subject should not be athletics or planning major changes in physical activity during the study to an extent that may interfere with the study outcome, as judged by the investigator
- •Weight change of > 3 kg within 2 months prior to screening
- •Surgically treated obesity
- •History or presence of significant cardiovascular disease such as heart failure, ischemic heart disease, stroke, transient ischemic attacks
- •Significant abnormalities on the ECG according to the investigators opinion. Additional exclusionary ECG values: QTcB > 450 milliseconds(ms), PR interval > 240 ms, QRS interval > 120 ms
- •Hypotension (i.e. supine systolic BP < 90 mm Hg) and/or symptomatic orthostatic hypotension (clinical symptoms of orthostatic hypotension associated with a decline ≥ 20 mm Hg in systolic BP at one minute after standing compared with the previous supine systolic BP obtained after 5 minutes of quiet rest) at screening visit
- •Hypertension (i.e. sitting diastolic BP ≥ 95 mm Hg and sitting systolic BP ≥ 155 mm Hg) as well as HR>90 bpm
- •Known HIV infection (no tests required)
- •Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma
- •Serologic evidence of active hepatitis B and/or C
- •History of cancer within the past 5 years, excluding treated basal cell carcinoma
- •Subjects previously treated with tesofensine
- •Subjects treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug
结局指标
主要结局
Effect on 24-h EE (energy expenditure) after 14 days dosing, adjusted for FFM(Fat-Free Mass) and FM (Fat Mass) changes
次要结局
- Data from questionnaires( Satiety & Appetite, POMS Brief)
- Safety & Tolerability
- Metabolic measures (Total triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin, Adiponectin, FFA, CCK, Ghrelin, and Leptin)
- 24-h fat oxidation, spontaneous physical activity, fecal excretion of energy and fat (respiratory chamber),Changes in body weight and composition
- Physical Measure(Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA, Spontaneous energy intake at lunch test
研究者
研究点 (2)
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