Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants

Exclusion Criteria

• •Subject has a clinically relevant disease which requires medication which as per the judgment of the Investigator would jeopardize the safety of the subject.
• •Subject has abnormal renal function test result or subject with a creatinine clearance \<60 mL/minute at the Screening Visit, confirmed on repeat testing.
• •Subject has elevated liver function test results at the Screening Visit.
• •Subject has bilirubin \>1.5X ULN at the Screening Visit.
• •Subject has FEV1/FVC \<0.7 and FEV1 \<80% predicted value at post-bronchodilator spirometry at the Screening Visit.
• •Subject has asthma condition at the Screening Visit.
• •Subject has received medication within 14 days or within 5 half-lives of the drug (whichever is longer) prior to Admission, which has an impact on cytochrome P450 (CYP) 2A6 activity.
• •Subject has a carbon monoxide (CO) breath test ≥ 10 ppm at the Screening Visit or Admission.
• •Subject has a body mass index (BMI) \<18.5 kg/m2 or BMI ≥35 kg/m2 at the Screening Visit.
• •Subject has a positive serology test for human immunodeficiency virus (HIV) 1/2, hepatitis B, or hepatitis C at the Screening Visit.
• •Subject has clinically significant ECG findings at the Screening Visit.
• •Subject has participated in a clinical study within 3 months prior to the Screening Visit.
• •Subject smokes cigarettes or uses other tobacco products.
• •Female subject of childbearing potential who is pregnant or breastfeeding.
• •Female subject of childbearing potential who does not agree to use an acceptable method of effective contraception..