Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches

Inclusion Criteria:Voluntary consent to participate in this study documented on the signed ICFSmoking history (self-reported at screening) of an average of at least 10 but no more than 30 factory-manufactured combustible cigarettes (either menthol or non-menthol) daily for at least 12 months prior to screening. Brief periods (ie, up to 7 consecutive days) of non-smoking during the 3 months prior to screening (eg, due to illness or participation in a study where smoking was prohibited) will be permittedPositive urine cotinine (≥ 500 ng/mL) at screeningFemale subjects who are heterosexually active and of childbearing potential (eg, neither surgically sterile at least 6 months prior to check-in nor postmenopausal with amenorrhea for at least 12 months prior to check-in with follicle-stimulating hormone [FSH] levels consistent with postmenopausal status) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:Hormonal (eg, oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to check-in, double barrier (ie, condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to check-in, an intrauterine device for at least 4 months prior to check-inExclusive partner who has been vasectomized for at least 6 months (inclusive) prior to check-inFemale subjects of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study.Female subjects who are of nonchildbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to check-in:Hysteroscopic sterilization (including Essure® or similar nonsurgical sterilization procedures); bilateral tubal ligation or bilateral salpingectomy; hysterectomy; bilateral oophorectomyOr be postmenopausal with amenorrhea for at least 12 months prior to check-in and have FSH levels consistent with postmenopausal statusWilling to comply with the requirements of the studyWilling to use all 3 on!® NP after the Product Trial at check-inWilling and able to abstain from cigarettes from Day 1 through the end of the study (EOS)Healthy adult males and females, 21 to 65 years of age, inclusive at screening, with subjects aged 46 to 65 years being fully vaccinated for COVID-19 (SARS-CoV-2) at least 14 days before the screening visit.Exclusion Criteria:Use of any type of tobacco- or nicotine-containing products other than manufactured cigarettes (eg, e-vapor products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) in the 7 days prior to check-inSelf-reported puffers (ie, adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale)Planning to quit smoking in the next 30 days (from screening visit)History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, existing respiratory diseases, immunologic, psychiatric, lymphatic, or cardiovascular disease, or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study resultsClinically significant abnormal findings on the vital signs, physical examination, medical history, electrocardiogram (ECG), or clinical laboratory results, in the opinion of the investigatorPositive test for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at screeningHistory or presence of any type of malignant tumorsCurrent evidence or any history of congestive heart failureDiabetes mellitus (fasting glucose ≥126 mg/L [7 mmol/L]) that is not controlled by diet/exercise alone, in the opinion of the investigatorAn acute illness (eg, upper respiratory infection, viral infection) requiring treatment with prescribed medicines within 2 weeks prior to check-inDentition that prevents subjects from using on!® NP productsAllergic to or cannot tolerate mint flavoring agents or phenylalanineAny planned surgery from the time of screening through EOSHistory of drug or alcohol abuse within 24 months prior to check-inFever (ie, body temperature >100.5°F) at screening or check-in. One recheck may be performed at the investigator's discretionBody mass index greater than 40.0 kg/m2 or less than 18.0 kg/m2 at screeningSystolic blood pressure >150 mmHg and/or diastolic blood pressure > 90 mmHg at screening or check-in, measured after being seated for at least 5 minutes. One recheck may be performed at the investigator's discretionEstimated creatinine clearance (by Cockcroft-Gault equation) < 80 mL/minute at screeningSerum alanine aminotransferase ≥1.5 times the upper limit of normal and/or aspartate aminotransferase ≥1.5 times the upper limit of normal at screeningPositive screen for alcohol (breath) or any of the following drugs of abuse (urine), regardless of the reason of use: amphetamines, methamphetamines, opiates, cannabinoids, or cocaine at screening or check-inFemale subjects who are pregnant (positive serum pregnancy test at screening or urine pregnancy test at check-in), lactating, or intend to become pregnant from screening through EOSUse of prescription or over-the-counter bronchodilator medication (eg, inhaled or oral ß-agonists) within 12 months prior to check-inUse of medications or foods known or are suspected to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, grapefruit, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to check-in or during the studyUse of antibiotic treatment within 2 weeks prior to check-inPlasma donation within 7 days prior to check-inDonation of blood or blood products (with the exception of plasma as noted above), had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to check-inParticipation in a previous clinical study for an investigational drug, device, biologic, or a tobacco product within 30 days prior to check-inParticipation in 2 or more Altria Client Services (ALCS) studies within the past 12-month period prior to check-inSubject or a first-degree relative (ie, parent, sibling, child, spouse/partner) is a current or former employee of the tobacco industry or a named party or class representative in litigation with any tobacco companySubject or a first-degree relative (ie, parent, sibling, child, spouse/partner) is a current employee of the study sitePositive result for coronavirus disease (COVID)-19 (SARS-CoV-2) test at screening or check-inOne or more "yes" answers to any of the questions on the COVID-19 (SARS-CoV-2) screening questionnaire (provided by the study site) at screening or check-in.Have been diagnosed with major depressive disorder or have a history of suicide attempt.

Source: ClinicalTrials.gov (NCT05664672). StuddyBuddy aggregates publicly available trial information.

Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches

Summary

Eligibility Criteria