Male or female subjects who are chronic smokers, but motivated to quit smoking will be recruited.
Conditions
Interventions
Product Name: EVT 302
Pharmaceutical Form: Tablet
CAS Number: 676479-06-4
Current Sponsor code: EVT 302
Other descriptive name: (S)-N-{1-[4-(3-Fluoro-benzyloxy)-phenyl] -5-oxo-pyrrolidin-3-y
Sponsors
Evotec Neurosciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 to 70 years of age. 2. Body Mass Index (BMI) > 18 and 90 mmHg and =150 mmHg and seated diastolic blood pressure must be >50 mmHg and =95 mmHg at screening and baseline. 9. Able and agrees to complete diary and questionnaires, communicate effectively with study personnel and be considered reliable, willing and cooperative in terms of compliance with the protocol requirements. 10. Voluntarily gives written informed consent to participate in the study. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female subjects currently pregnant and/or nursing. Non-pregnancy of women with childbearing potential will be confirmed by serum pregnancy tests conducted at screening. Women without childbearing potential are those hysterectomised, sterile or post menopausal with amenorrhoea of least one year duration. Women of childbearing potential will agree to use an acceptable form of birth control (contraceptive pill and barrier contraception - partner using condom or subject using spermicide, diaphragm or contraceptive sponge) during the study and for at least 2 months after completing the study. Male subjects must agree to use either double-barrier contraception or their partner must use the contraceptive pill during the study and for at least 2 months after completing the study. 2. Has a history of anaphylaxis with clinical signs, a documented immunological hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug. A history of rash after penicillin intake without hospitalisation is acceptable. 3. Has a history or presence of abuse of alcohol, licit or illicit drug substances within the last 12 months (abuse of alcohol defined as intake of more than 15 units of alcohol weekly for men and 10 units weekly for women where 1 unit corresponds to 285 mL beer, 125 mL wine and 25 mL spirit, respectively), or a positive drug screen for drugs of abuse (including tetrahydrocannabinol for marijuana and breath test for alcohol). 4. History of or current significant medical (e.g. cardiovascular, hepatic, endocrine, bronchopulmonary and neurological, but not exclusively) or psychiatric disorder (including schizophrenia, seasonal affective and other mood disorders, history of or current tendency for suicidal thoughts and suicidal attempts) that may pose a risk to the subject in this study or adversely interact with study measures or the subject’s ability to participate in the study. Mild stable forms of diseases such as chronic obstructive pulmonary disease (COPD) are acceptable, and potentially eligible on a case-by case decision between Sponsor and Investigator. 5. Major depressive disorder within the last 12 months or a Hamilton Rating Scale for Depression (HAM-D) 17 score of more than 12 at screening. 6. History or presence of cataract (or abnormality identified by slit lamp examination during screening), uveitis, eye trauma or eye irradiation. Minor ophthalmological findings outside lens and cornea discovered during the ophthalmological screening should not lead to exclusion. 7. Use of any medication that may adversely interact with study measures (antidepressants, typical and atypical antipsychotics, anxiolytics and hypnotics, antiepileptics, others); recent or regular use of an opioid medication. 8. Use of other MAO inhibitors, pethidine, SSRIs, TCAs, nasal and oral decongestants or cold medicines containing ephedrine, pseudoephedrine, other sympathomimetics (including epinephrine and norepinephrine) and any medication forbidden to be co-administered with MAO inhibitors (e.g. linezolid, albuterol). Occasional use of non-sedative anti-histamines is acceptable. 9. 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. 10. Blood donation within the last two months or planned during the study and two months afterwards. 11. Unwillingness to attend study visits, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: .To evaluate the efficacy and safety of EVT 302 compared with placebo as an aid to smoking cessation in chronic cigarette smokers. ;Secondary Objective: .To assess the efficacy of EVT 302 when combined with NRT. .To assess the efficacy of EVT 302 compared with placebo in reducing the symptoms of nicotine withdrawal. ;Primary end point(s): The primary endpoint for this study will be the 4-week CQR for the last four weeks of treatment (Weeks 5 to 8). Analysis of the primary efficacy outcome will be performed using an appropriate non parametric method such as the Chi-Squared test or Fisher’s Exact test. Only the difference between EVT 302 and placebo will be formally tested. For all other treatment comparisons, confidence intervals for the treatment effect will be calculated. A confirmatory analysis on the proportion of responders will be performed using a logistic regression with treatment group as a factor. Potential prognostic factors reported during the screening period will also be examined. Summary statistics by treatment group and visit will be produced for all efficacy and safety parameters, together with changes from baseline if applicable. TEAEs will be classified according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary and will be tabulated by preferred term and system organ class, by both severity and relationship to study drug. | — |
Countries
Germany
Outcome results
None listed