Status:
COMPLETED
Effect of Tesofensine on Energy Balance in Humans.
Lead Sponsor:
NeuroSearch A/S
Conditions:
Obesity
Eligibility:
MALE
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Purpose: To evaluate the effect of tesofensine on energy balance
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00428415
Start Date
March 1 2007
End Date
December 1 2007
Last Update
March 5 2008
Active Locations (1)
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1
NeuroSearch A/S
Ballerup Municipality, Denmark, 2750