Clinical trial NCT00622752 (phase 2, status: completed)
Conditions: smoking cessation
ICD codes: Y36.881S, Y36.891S, Y36.880S, Y36.881A, Y36.881D, Y36.890S, Y36.891A
Drugs: evt 302, 10 mg, placebo, nicotine replacement therapy (nrt)
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1CCC[C@H]1C1=CN=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects between 18 and 55 years of age, inclusive

          -  BMI between 18 and 30, minimum weight of 50 kg

          -  Negative urine drug & alcohol screen

          -  Able to comply with tyramine-restricted diet

          -  Smoking of ≥17 and ≤34 cigarettes per day for the past year and have not tried to quit
             smoking in the 3 months prior to screening

          -  Subjects are willing and able to quit for about 12 hours in each of three subsequent
             study periods

          -  Previous experience of craving following smoking cessation

          -  Breath CO between 15 ppm and 20 ppm and cotinine in saliva and plasma at least 250
             ng/mL at screening

          -  Liver function test results not above 1.5 times the upper normal limit (UNL) at
             screening visit and at re-assessment during the study.

        Exclusion Criteria:

          -  Participation in another clinical study within 60 days of screening

          -  Evidence of active significant psychiatric or neurological disease or dependency other
             than cigarettes

          -  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

          -  Known hypersensitivity to MAO inhibitors or any substance that is contained in the
             study formulations

          -  Known allergy to plasters or NRT patches

          -  Previous participation in another study with EVT 302

          -  Currently receiving treatment for smoking cessation

          -  Current use of tobacco products other than cigarettes

          -  Require treatment with any medication

          -  Subject with a clinically relevant abnormal 12-lead ECG recording or QTcB/F >430 ms

          -  Use of a prescription medicine 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)

          -  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)

          -  Daily consumption of more than 5 cups of tea or coffee, or more than 1.0 litre of
             xanthine-containing drinks

          -  Recent myocardial infarction, unstable or worsening angina pectoris, prince metal
             angina, severe arrhythmias, recent stroke.

          -  Creatinine clearance (CLR) calculated according to the formula by Modification of Diet
             in Renal Disease (MDRD) of <80 mL/min