EUCTR2007-006236-63-DE进行中（未招募）不适用
A double-blind, randomized, placebo- and NRT-controlled Phase II study to assess the effects of EVT 302 alone and in combination with NRT on craving and withdrawal in healthy male smokers deprived of cigarettes
Evotec Neurosciences GmbH0 个研究点开始时间: 2007年11月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male subjects between 18 and 55 years of age, inclusive
- •2. Body mass index (BMI) in the range of 18 kg/m2 and 30 kg/m2, inclusive, and
- •minimum weight of 50 kg
- •3. In good general health and is expected by the Investigator to complete the clinical
- •study as designed
- •4. Negative urine drug screen for cannabis, opiates, cocaine metabolites,
- •amphetamines, barbiturates and benzodiazepines including ethanol at screening
- •and baseline
- •5. Have adequate hearing, vision, and language skills to follow the study conditions
- •6. Readiness to comply with tyramine-restricted food intake
- •7. Smoking of =17 and =34 cigarettes (i.e. between 1 and 2 packs) per day for the
- •past year and have not tried to quit smoking in the 3 months prior to screening
- •8. Subjects should smoke their preferred cigarette brand during the study and must
- •not change it during the entire study participation
- •9. Subjects are willing and, in the Investigator’s opinion, able to quit for about
- •12 hours in each of three subsequent study periods
- •10. Subjects are expected to experience craving symptoms after smoking cessation
- •as known from previous attempts to quit smoking
- •11. Breath CO at least between 15 ppm and 20 ppm and cotinine in saliva at least 250 ng/mL at screening
- •12. Liver function test (LFT) results (Alanine aminotransferase [ALT], Aspartate
- •aminotransferase [AST], Alkaline phosphatase [ALP], total bilirubin and Gammaglutamyl transferase [GGT]) not above 1.5 times the upper
- •normal limit (UNL) at screening visit and at re-assessment during the study.
- •13. Have voluntarily provided informed consent and signed an informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participation in another clinical study with an investigational medicinal product
- •(IMP) within the 60 days before screening
- •2. Inability to understand the protocol requirements, instructions and study-related
- •restrictions, the nature, scope, and possible consequences of the study
- •3. Unlikely to comply with the protocol requirements, instructions and study-related
- •restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and
- •improbability of completing the study
- •4. Evidence of active significant psychiatric or neurological disease or dependency
- •other than cigarettes
- •5. Are known to have or are a carrier of the hepatitis B surface antigen (HBsAg),
- •hepatitis C virus (HCV) antibody, has a positive result to the human
- •immunodeficiency virus-1 and/or 2 (HIV-1 and/or HIV-2) antibodies
- •6. Subject is expected to be able to cease smoking easily for days without
- •experiencing craving and smoking urges
- •7. Known hypersensitivity to MAO inhibitors or any substance that is contained in the
- •study formulations
- •8. Known allergy to plasters or NRT patches
- •9. Previous participation in another study with EVT 302
- •10. Are currently receiving treatment for smoking cessation
- •11. Are currently using tobacco products other than cigarettes (e.g. pipes, cigars,
- •snuff or chewing tobacco)
- •12. Require treatment with any medication
- •13. Blood or plasma donation of more than 500 mL in the 3 months before allocation
- •or of 50 mL in the 2 weeks before the first dosing
- •14. Subject with a clinically relevant abnormal 12-lead ECG recording or QTcB/F
- •15. Use of a prescription medicine during within 14 days or 5 half-lives, whichever is
- •the longer, of the start of dosing, or use of an over-the-counter medication during
- •the 7 days before the study, including herbal remedies, but excluding paracetamol
- •and vitamin supplements (provided intake does not exceed the daily
- •recommended allowance)
- •16. Subjects must not be planning to father a child or donate sperm, during the study
- •and 3 months after the end of the study. Acceptable methods of contraception
- •comprise barrier contraception and a medically accepted contraceptive method for
- •the female partner (intra-uterine device with spermicide, hormonal contraceptive
- •since at least 2 month)
- •17. Subject is the Investigator or any sub-investigator, research assistant, pharmacist,
- •study coordinator, other staff or relative thereof directly involved in the conduct of
- •18. Presence or history of severe adverse reaction to any drug
- •19. Daily consumption of more than 5 cups of tea or coffee, or more than 1.0 litre of
- •xanthine-containing drinks
- •20. Treatment in the previous 3 months with any drug known to have a well-defined
- •potential for toxicity to a major organ
- •21. Vulnerable subjects (e.g. persons kept in detention)
- •22. Recent myocardial infarction, instable or worsening angina pectoris, prince
- •metal angina, severe arrhythmias, recent stroke.
- •23. Creatinine clearance (CLR) calculated according to the formula by
- •Modification of Diet in Renal Disease (MDRD) of <80 mL/min and that in the
- •opinion of the Investigator indicates renal impairment
- •CLR will be calculated from serum creatinine values at Screening (Scr), using
- •the following formula:
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