ISRCTN18302793已完成未知
An open label, randomized, controlled, crossover study to measure nicotine pharmacokinetics using the JUUL ENDS with existing and new vaporization pods and a combustible cigarette in healthy adult subjects
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33486526/ (added 03/03/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •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)
排除标准
- •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
研究者
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