A study to examine the delivery of nicotine into the blood of people when they use Juul e-cigarettes with different pod designs
- Conditions
- se of e-cigarettesNot Applicable
- Registration Number
- ISRCTN18302793
- Lead Sponsor
- JUUL Labs Inc
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33486526/ (added 03/03/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
1. Healthy, adult, male or female smoker, 21 to 65 years of age, inclusive, at the Screening visit
2. BMI between 18 to 35 kg/m2, inclusive
3. Healthy based on medical history and screening assessments, in the opinion of the Investigator
4. Current smoker, for at least 12 months prior to the Screening visit. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study or trial where smoking was prohibited) during that time will be permitted at the discretion of the PI
5. Currently smokes at least 10 manufactured combustible, non-menthol cigarettes per day (CPD), as self-reported at Screening visit. Subjects may also be dual-using cigarettes and ENDS products
6. Has a positive urine cotinine (= 200 ng/mL) at the Screening visit
7. Has an exhaled CO > 10 ppm at Screening visit
8. 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:
8.1. Hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to Assessment Day 1
8.2. Double barrier method (e.g., condom with spermicide, diaphragm with spermicide) at screening
8.3. Intrauterine device for at least 3 months prior to Assessment Day 1
8.4. A partner who has been vasectomized for at least 6 months prior to Assessment Day 1
8.5. Abstinence beginning at least 6 months prior to screening
9. A female subject of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Assessment Day 1:
9.1. Hysteroscopic sterilization
9.2. Bilateral tubal ligation or bilateral salpingectomy
9.3. Hysterectomy
9.4. Bilateral oophorectomy
9.5. Or postmenopausal with amenorrhea for at least 1 year prior to Check-in and have follicle-stimulating hormone (FSH) levels consistent with postmenopausal status
10. Is willing to comply with the requirements of the study, including a willingness to use the study products during the study
11. Provides voluntary consent to participate in this study documented on the signed informed consent form (ICF)
1. Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator. This includes any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
2. Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of an investigator
3. Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 28 days prior to Check-in
4. Has a fever (> 100.5°F) at the Screening visit or on Assessment day(s)
5. Positive result for urine drugs of abuse test or alcohol breath test at the screening visit. If a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the PI should obtain documentation that;
5.1. Confirms the subject’s use of the prescribed medication
5.2. The prescribed medication will cause a false positive drug test
6. Has or has a history of diabetes mellitus, asthma, or chronic obstructive pulmonary disease
7. Has a systolic blood pressure < 90 mmHg or > 150 mmHg, diastolic blood pressure < 40 mmHg or > 95 mmHg, or heart rate < 40 bpm or > 99 bpm at Screening
8. 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)
9. Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator
10. Has participated in a previous clinical study or trial for an investigational drug, device, biologic, or tobacco product within 30 days prior to Day 1
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 Assessment Day 1
12. If female, the subject is pregnant, has a positive serum pregnancy test at screening, is lactating, breastfeeding, or intends to become pregnant during the time period from Screening through the end of study
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 Assessment Day 1
14. Has used any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or bupropion (Zyban®) within 30 days prior to Assessment Day 1
15. Requires concomitant treatment with prescription or non-prescription products that contain pseudoephedrine (e.g., nasal/sinus decongestants)
16. Negative response (i.e., u
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Baseline-adjusted and unadjusted plasma nicotine pharmacokinetic (PK) parameters following the 5-minute controlled product use sessions for each study product. The following PK parameters will be determined: AUC0-60, Cmax and Tmax (unadjusted only). These will be determined following the measurement of blood (plasma) nicotine levels in samples drawn at the following timepoints relatives to initiation of the first inhalation: -5, 1.5, 3, 5, 6, 7, 8, 10, 15, 30 and 60 minutes.
- Secondary Outcome Measures
Name Time Method <br> 1. Baseline-adjusted and unadjusted plasma nicotine PK parameters following the 5-minute ad libitum product use sessions for each study product. The following PK parameters will be determined: AUC0-60, Cmax and Tmax (unadjusted only). These will be determined following the measurement of blood (plasma) nicotine levels in samples drawn at the following timepoints relatives to initiation of the first inhalation: -5, 1.5, 3, 5, 6, 7, 8, 10, 15, 30 and 60 minutes.<br> 2. Subjective effects following use of the study products, assessed using the modified product evaluation scale (mPES) at a single timepoint on each assessment day, immediately after completion of the 30-minute blood draw<br>