ISRCTN53244525已完成未知
A randomized, open-label, crossover study to characterize nicotine pharmacokinetic parameters following use of novel nicotine-containing products for oral use compared to combustible cigarettes and nicotine gum in healthy adult smokers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Willing and able to give written informed consent for participation in the study
- •2. Healthy male or female subject aged 19-64 years inclusive
- •3. Body Mass Index (BMI) =18.5 and =30.0 kg/m² at Screening
- •4. Subject who currently smokes factory-made combustible cigarettes (the ISO tar yield =6 mg), who typically smokes at least 10 and a maximum of 30 cigarettes per day, who daily smokes the cigarettes (more than 5 days per week), and who has been smoking cigarettes for at least 1 year prior to the Screening
- •5. Positive urine cotinine test (>200 ng/ml) at Screening
- •6. Clinically normal medical history, physical findings, vital signs, ECG, low dose of computed tomography of lungs and laboratory values at the time of Screening, as judged by the Investigator
- •7. Subjects who are healthy, as judged by the Investigator, based on all available assessments at Screening and PK assessment days (safety laboratory testing, spirometry [forced expiratory volume in 1 second {FEV1} s/forced vital capacity {FVC} >0.7 at post-bronchodilator spirometry, post-bronchodilator FEV1 >80% predicted value, and post-bronchodilator FVC >0.8], vital signs, physical examination, 12-lead ECG, and medical history)
- •8. Subjects who are able to place a pouch of Nordic Spirit 9 mg between gum and lip, in a 30-minute period without discomfort (the subjects will be asked to try a pouch of Nordic Spirit 9 mg during Screening)
- •9. Women of childbearing potential (WOCBP) must be willing to use a sufficient contraceptive method for the duration of the study, this includes mechanical barrier (e.g., a male condom or a female diaphragm), combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal anticonception associated with inhibition of ovulation [oral, injectable, implantable], IUD or IUS. Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject
- •10. Negative to the coronavirus infection (PCR test on Screening, and antigen test on the day of check-in to the study site)
排除标准
- •1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
- •2. Any clinically significant illness, a medical/surgical procedure or trauma within 2 weeks prior to the first day of PK assessment
- •3. Malignancy within the past 5 years except for in situ removal of basal cell carcinoma
- •4. Any surgery within 6 months of the Screening visit that could negatively impact the subject's participation, as judged by the Investigator
- •5. Any planned major surgery within the duration of the study
- •6. Medical history of seizures (single occasions of febrile seizure in childhood excluded)
- •7. Clinically significant liver disease (including total bilirubin, alkaline phosphatase, LDH, AST or ALT) as judged by the Investigator Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C virus antibodies and HIV
- •8. Positive screen for drugs of abuse or alcohol at Screening or on admission to the Site prior to any use of the investigational product
- •9. Systolic blood pressure of >140 mmHg or diastolic blood pressure of >90 mmHg, at least 5 minutes in the seated position
- •10. Poor peripheral venous access, as judged by the Investigator
- •11. Female subjects who are pregnant or who are currently breastfeeding
- •12. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator
- •13. Presence or history of drug abuse and/or anabolic steroids, as judged by the Investigator
- •14. Subjects who have used any tobacco/nicotine-containing products (including electronic cigarettes and heat-not-burn tobacco products) or NRT medications, other than factory-made combustible cigarettes within 14 days of Screening
- •15. Subjects who, prior to enrolment, are planning to quit tobacco use during the study period or are postponing a quit attempt to participate in the study. All subjects will be informed that they are free to quit tobacco use and withdraw from the study at any time
- •16. Any use of prescription or over-the-counter bronchodilator medication (e.g., inhaled or oral ß-adrenergic agonists, cholinolytics or theophylline) to treat a chronic condition within the 12 months prior to the first day of PK assessment
- •17. Any medication (prescription or over-the-counter [OTC]) within 14 days or within five half-lives of the drug (whichever was longer) prior to the first day of PK assessment, which has an impact on CYP2A6 activity
- •18. Plasma donation within one month of Screening or blood donation (or corresponding blood loss – 450 ml) during the 3 months prior to Screening
- •19. Planned treatment or treatment with another investigational product within 3 months prior to the first day of PK assessment. Subjects consented and screened but not dosed in previous phase I studies are not excluded
- •20. Subjects who are employed by the tobacco industry, the clinical site, or handle unprocessed tobacco as part of their job
- •21. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
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