A Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers

• Has signed and dated the informed consent document in person before participating in any study-specific procedures, indicating the participant has been informed of all pertinent aspects of the study.
• Absence of clinically relevant abnormalities as judged by the investigator on the basis of a detailed medical history, physical examination, oral health, vital signs, 12-lead electrocardiogram, and clinical laboratory tests.
• Has a Body Mass Index (BMI) between 18.5 and 34.9 kg/m2 with a total body weight ≥50.0 kg.
• Daily conventional cigarette smoker, smoking within 30 minutes of waking, who have been smoking for at least one-year preceding inclusion.
• Ability to fast for at least 12 hours before study drug administration and up to 4 hours after study drug administration and consume standard food.
• For females: Postmenopausal state or premenopausal/perimenopausal state or child bearing potential with an effective means of contraception during the study and for at least 30 days after the final dose of IP.
• Males must be willing to utilize an acceptable form of birth control with spouse/partner during the study and for at least 30 days after the final dose of IP.
• Able to read and understand English.
• Is able to comprehend the requirements of the study (based upon clinical site personnel's assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol.

Exclusion Criteria:

• Is hypersensitive, intolerant, or experienced an allergic reaction to the active ingredient(s) or excipients of drug products used in the study.
• Female participants who are pregnant (as confirmed by a positive pregnancy test), breastfeeding, or planning to become pregnant during the study period will be excluded.
• Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV).
• Has a positive test for drugs of abuse and/or alcohol at screening and study check-in.
• Has hepatic impairment
• Has a history of clinically significant gastrointestinal surgery that, in the opinion of the Investigator, may affect the safety of the participant.
• Clinically significant medical conditions that are unstable or uncontrolled and may interfere with a participant's participation in the study in the opinion of the medically qualified investigator.
• History of alcoholism or substance abuse (including marijuana), as judged by the Investigator, within 6 months preceding this study.
• History of epilepsy or seizures.
• Presence or history of significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction and any other conditions of the mucosal surface of the mouth that in the opinion of the investigator may affect IP absorption.
• Has the presence of a tongue piercing or a history of tongue piercing within 90 days prior to the Screening visit.
• Dosed with another investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the treatment visit, or participants who have received the last dose of IP more than 30 days or 5 half-lives (whichever is longer) prior to the treatment visit, but who are on an extended follow-up.
• Has pre-planned surgery, procedures, or personal commitments that would interfere with the conduct of the study.
• Is related to persons involved directly in the conduct of the study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees or contractors of the Sponsor or Kenvue subsidiaries, and their family).
• Reports difficulty fasting or consuming standardized meals.
• The participant, in the opinion of the PI/designee , is unlikely to comply with the protocol or is unsuitable to participate in the study due to any other reason.
• Use of other smoking cessation medications or aid(s) within 28 days before screening and during the study (e.g., NRT, buproprion, varenicline, cytisine, counselling, apps, acupuncture, or hypnosis).
• Use of any prescription or non-prescription medications within 7 days or 5 half-lives (whichever is longer) prior to first dose, and use of vitamins, dietary supplements, or herbal products within 7 days prior to administration.
• Uncontrolled hyperthyroidism or phaeochromocytoma.
• History of recent or unstable cardiovascular disease, a gastric or peptic ulcer, esophagitis, or diabetes not controlled by oral medication only.
• Other severe, acute or chronic, medical or psychiatric condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this study.