Nicotine exposure Not Applicable
Conditions
Interventions
Randomization:
The study will enroll 30 adult smokers in each study part (A and B), smokers of non-menthol cigarettes in Part A and smokers of menthol cigarettes in Part B, to ensure 28 subjects compl
subjects will be provided Tobacco or Menthol flavors based on the study Part into which they are enrolled. For study products the subjects wish to try, one pod of each will be dispensed
requested products with 5% nicotine will be provided first. Subjects who do not tolerate or object to further using a product will be considered to have failed screening and should not be administered
Sponsors
Juul (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in the study: 1. Provides voluntary consent to participate in this study documented on the signed ICF(s). 2. Adult, male or female smoker, 22 to 65 years of age, inclusive, verified by government-issued ID, at the Screening visit. 3. Has been a smoker = 12 months prior to Screening. 4. Currently smokes an average of =10 manufactured combustible cigarettes per day (CPD), as self-reported at Screening. 5. Has past 30-day history of some day or everyday ENDS use. 6. Has a positive urine cotinine (=200 ng/mL) at the Screening visit and Check-in/Day -1. 7. Has an exhaled carbon monoxide (eCO) =10 ppm at the Screening visit. 8. Completes the screening process within 28 days prior to study Day -1. 9. Is willing to comply with the requirements of the study, including a willingness to use the study products during the study and to stop smoking during the required abstention periods in the study. 10. A female subject of childbearing potential must have been using one of the following forms of contraception, and agree to continue using it through the completion of the study: 10.1. Hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to study Day 1; 10.2. Double-barrier method (e.g., condom with spermicide, diaphragm with spermicide) from Day 1; 10.3.3 Intrauterine device for at least 3 months prior to study Day 1; 10.4. Abstinence beginning at least 6 months prior to Day 1; 10.5. a partner who has been vasectomized for at least 6 months prior to Day 1. 11. A female subject of non-childbearing potential must be postmenopausal with amenorrhea for at least 1 year prior to study Day 1 and follicle-stimulating hormone (FSH) levels consistent with postmenopausal status or have undergone one of the following sterilization procedures at least 6 months prior to study Day 1: 11.1. Hysteroscopic sterilization; 11.2. Bilateral tubal ligation, occlusion, or bilateral salpingectomy; 11.3. Hysterectomy; 11.4. Bilateral oophorectomy
Exclusion criteria
Exclusion criteria: 1. Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, laryngeal, oncologic, urologic, pulmonary (asthma, chronic obstructive pulmonary disease), immunologic, psychiatric, cardiovascular disease (hypertension, heart failure, chronic coronary syndrome, post-myocardial infarction status), diabetes mellitus, 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 results. 2. Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, electrocardiogram (ECG), in the opinion of an Investigator and any abnormal findings in clinical laboratory results at the Screening visit. 3. Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 28 days prior to study Day -1. 4. Has a positive test result to HIV Ag/Ab combo, HBsAg or HCVAb at Screening. 5. Has a fever (>100.4°F [38oC]) at the first Screening visit or at Check-in/Day -1. 6. Has a body mass index (BMI) = 40 kg/m2 or 150 mmHg, diastolic blood pressure (DBP) 95 mmHg, or HR 99 bpm at Screening. 10. Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (nicotine, flavor, benzoic acid, propylene glycol and glycerol). 11. Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Screening. 12. Has donated blood or blood products >500 mL, had significant blood loss, or received whole blood or a blood product transfusion within 56 days or has donated plasma within 7 days prior to Screening. 13. If female, the subject is pregnant, has a positive pregnancy test at the Screening visit or at Check-in/Day -1, is lactating, breastfeeding, or intends to become pregnant during the time period from Screening through the follow-up call. 14. Has used medications known to interact with cytochrome P450 (CYP) 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, 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 study Day 1. 15. Has used medications reported to interact with nicotine,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum baseline concentration (Cmax-BL) and the area under the curve from 0 to 120 minutes baseline (AUC0-120-BL) of the JUUL2 ENDS Devices with JUUL2 pods (Virginia Tobacco or Fresh Menthol flavors, 3% and 5% nicotine) compared to the subject’s usual brand (UB) of combustible cigarettes, under controlled puffing conditions (10 puffs of 3 seconds each, spaced 30 seconds apart) measured using blood samples drawn at approximately -5, 1.5, 3, 5, 6, 7, 8, 10, 15, 30, 60, and 120 minutes after first product use | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Nicotine pharmacokinetics (PK) while using the JUUL2 ENDS Devices with JUUL2 pods, Virginia Tobacco or Fresh Menthol flavors, 3% and 5% nicotine, as compared to the subject’s UB of combustible cigarettes during controlled and 5-minute ad libitum puffing conditions measured using blood samples drawn at approximately -5, 1.5, 3, 5, 6, 7, 8, 10, 15, 30, 60, and 120 minutes after first product use 2. Nicotine PK while using a commercially available ENDS Device with pod during controlled and 5-minute ad libitum puffing conditions measured using blood samples drawn at approximately -5, 1.5, 3, 5, 6, 7, 8, 10, 15, 30, 60, and 120 minutes after first product use 3. The following subjective assessments will be assessed with the use of the JUUL2 ENDS Devices with JUUL2 pods, Virginia Tobacco or Fresh Menthol flavors, 3% and 5% nicotine, a commercially available ENDS Device with a pod, and the subject’s UB of combustible cigarettes (the responses will be summarized in descriptive statistics tables): 3.1. Subjective responses to the use of study products measured using the Modified Product Evaluation Scale (mPES) at approximately 30 minutes post-start of each product use session (controlled and ad libitum use session, after collecting the 30-minute blood sample during both the controlled and ad libitum product use sessions) 3.2. Subjective responses to the liking of the products measured using the Product-Liking Questionnaire at approximately 30 minutes post-start of each product use session (controlled and ad libitum use session, after collecting the 30-minute blood sample during both the controlled and ad libitum product use sessions) 3.3. Subjective responses to the urge to smoke measured using the Urge to Smoke a Cigarette Questionnaire approximately 10 minutes prior to first puff, and at 5, 10, 15, 30, and 45 minutes relative to the first puff during each puffing session (controlled and ad libitum use session, after collecting any coincident blood sample during both the | — |
Countries
United States of America
Contacts
Public ContactSandra Miller
Outcome results
None listed