Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT02794220
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed written informed consent.
* Males aged 18-65 years.
* Subject with a Body Mass Index (BMI) of 18-30 Body Mass Index = Body weight (kg) / \[Height (m)\]2.
* Regular moderate cigarette smokers (approximately 10 to 20 cigarettes per day for at least 5 years) who are not intending to make a quit attempt during the study.
* No obvious symptoms of ill health as determined during the pre-study medical examination (to be performed within 4 weeks of the first dose).
* Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG), including normal resting ECG with QTcB interval of less than 440 ms determined within 4 weeks of the first dose.
* No clinically significant abnormalities in blood pressure values (the differences between supine and standing BP are less than 20 mmHg) with no symptomatic evidence of postural hypotension.
* Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 4 weeks of the first dose.
* Subject with a negative urinary drugs of abuse screen (excluding nicotine), determined within 4 weeks of the first dose (N.B. a positive alcohol result may be repeated at the discretion of the Investigator).
* Subject with negative HIV and Hepatitis B and C results.
To be re-confirmed at Day 0:
* Subject continues to meet all screening inclusion criteria.
* Subject with a negative urinary drugs of abuse screen (including alcohol) prior to dosing
Exclusion Criteria:
* To be confirmed at Screening Visit:
* Evidence of renal, hepatic, central nervous system, respiratory (including COPD), cardiovascular or metabolic dysfunction.
* Known allergy to any ingredients of the study medication.
* A history of or current drug or alcohol abuse.
* Inability to communicate well with the Investigator/study staff (i.e., language problem, poor mental development or impaired cerebral function).
* Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months (N.B. washout period between trials defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study..
* Donation of 450ml or more blood within the previous 3 months.
* Any other clinically significant medical history, in theInvestigator's opinion, including conditions which might affect drug absorption, metabolism or excretion.
* Unlikely to comply with trial visit schedule or with trial medication dosing requirements.
* Severe intercurrent illness which, in the opinion of the Investigator, may put the subject at risk when participating in the trial or may influence the results of the trial or affect the subjects' ability to take part in the trial.
* Excessive intake of alcohol, defined as a regular maximum weekly intake of greater than 28 units for men (1 unit equals half a pint of beer, 1 small glass of wine or 1 x 25 mL measure of spirits) within the last 6 months.
* Treatment with smoking cessation medications (bupropion, Champix, any NRT) within 8 weeks of the planned first nicotine dosing occasion.
* Treatment with prescription medications within 21 days or over-the-counter medication within 72 hours of the planned first nicotine dosing occasion.
* Clinical judgement by the Investigator that the subject should not participate in the study for any other reason.
To be re- confirmed at Day 0:
* Development of any exclusion criteria since screening
* Receipt of any medication since screening visit that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02794220
Study Brief:
Protocol Section:
NCT02794220