Nicotine exposure Not Applicable
Conditions
Interventions
Randomisation:
Forty-four participants, twenty-two in each Study Part (Part A is tobacco flavored products and Part B is menthol flavored products), 7 participants
in e
subjects will be provided Tobacco or Menthol flavours depending upon the Study Part in which they potentially will be randomized. Subjects will be assessed on their ability to properly complete the co
Sponsors
Juul Labs Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provides voluntary consent to participate in this study documented on the signed ICF(s). 2. Adult, male or female smoker, 21 to 65 years of age, inclusive, at the Screening visit. 3. Has been a smoker = 12 months prior to Screening. 4. Currently smokes an average of =10 manufactured combustible CPD, as self-reported at Screening. 5. Has past 30-day history of some day or every day ENDS use. 6. Has a positive urine cotinine (=200 ng/mL) at the Screening visit and Check-in. 7. Has an eCO =10 ppm at the Screening visit and Check-in. 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 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. 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 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, 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 for COVID-19. 5. Has a positive test result to HIV Ag/Ab combo, HBsAg or HCVAb. 6. Has a fever (>100.4°F [38oC]) at Screening visit or at Check-in. 7. Has a positive urine test result for alcohol or drugs of abuse, or positive alcohol breath test at the Screening visit or at Check-in. If a positive urine drug test is observed, and it is believed that the positive urine test is due to prescription drugs, the PI should obtain documentation that; a. confirms the subject’s use of the prescribed medication, and b. the prescribed medication will cause a false positive drug test. 8. Has an SBP 150 mmHg, DBP 95 mmHg, or HR 99 bpm at Screening. 9. Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (nicotine, flavour, benzoic acid, propylene glycol and glycerol). 10. Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Screening. 11. Has donated blood or blood products >500 mL, had significant blood loss, or received whole blood or a blood product transfusion within 3 months prior to Screening. 12. If female, the subject is pregnant, has a positive pregnancy test at the Screening visit or at Check-in, is lactating, breast feeding, or intends to become pregnant during the time period from Screening through EOS. 13. 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. 14. Has used medications reported to interact with nicotine, including theophylline, ropinirole, and clozapine, within 14 days or 5 half-lives of the drug, whichever is longer, prior to study Day 1. 15. Has used any prescription smoking cessation treatments,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax-BL and AUC0-120-BL under controlled puffing conditions (i.e., 10 puffs of 3 seconds each, spaced 30 seconds apart) using blood samples for nicotine analysis collected approximately 5 minutes prior to initiation of the first product use (i.e., -5 minutes ± 2, the baseline sample) and approximately 1.5, 3, 5, 6, 7, 8, 10, 15, 30, 60, and 120 minutes after initiation of study product use | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Nicotine pharmacokinetics (PK) during controlled and 5-minute ad libitum puffing conditions using blood samples for nicotine analysis collected approximately 5 minutes prior to initiation of the first product use (i.e., -5 minutes ± 2, the baseline sample) and approximately 1.5, 3, 5, 6, 7, 8, 10, 15, 30, 60, and 120 minutes after initiation of study product use 2. Subjective assessments: 2.1. Modified Product Evaluation Scale (mPES) completed 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). 2.2. Product-Liking Questionnaire completed 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). 2.3. Urge to Smoke a Cigarette Questionnaire administered at 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 controlled and ad libitum product use sessions). 2.4. Future Intent to Use the Product Questionnaire completed 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. Products use: changes in pod weights while using ENDS study products. All pods (without cap) will be weighed before and after both the controlled and ad libitum sessions for each subject. The change in weight between these two measurements will be recorded. 4. Puffing topography while using JUUL2 test products (collected by device). | — |
Countries
Poland
Contacts
Public ContactSandra Miller
Outcome results
None listed