ISRCTN14301360已完成未知
A randomised, controlled, multi-centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional combustible cigarette to the glo tobacco heating product
British American Tobacco (Investments) Ltd0 个研究点目标入组 180 人开始时间: 2016年12月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5567437/ protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29912406 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subjects will be males or females of Japanese origin and between 23 and 55 years of age, inclusive
- •2. Subjects will have a body mass index (BMI) between 17.6 and 32.0 kg/m2, inclusive; a body weight exceeding 50 kg (males) or 40 kg (females)
- •3. Subjects will be in good health, as judged by the PI or designee based on medical history, physical examination, vital signs assessment, 12-lead ECG, clinical laboratory evaluations and lung function tests
- •4. Subjects will have given their written informed consent to participate in the study and will have agreed to abide by the study restrictions
- •5. Subjects must demonstrate the ability to comprehend the Informed Consent Form (ICF), be able to communicate well with the PI or their appropriately qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the PI or their appropriately qualified designee
- •6. Subjects will be willing to refrain from consuming alcohol within 72 hours prior to Screening and Admission
- •7. Subjects will be willing to refrain from consuming cruciferous vegetables, and grilled, fried or barbequed food, and avoid being in the presence of the cooking of cruciferous vegetables, and grilled, fried or barbequed food for 48 hours prior to Admission. Subjects will also be willing to avoid food containing poppy seeds for 3 days before both screening and Admission
- •8. Subjects will be regular smokers of factory-made cigarettes whose chosen brand is within the ISO tar bands 6 mg to 8 mg
- •9. Subjects will have smoked their chosen brand for a minimum of 6 months and will have smoked for at least 3 consecutive years prior to Screening
- •10. Subjects will typically smoke at least 10 and a maximum of 30 cigarettes per day and must have a urine cotinine level >200 ng/mL and an exhaled breath CO level >10 ppm at Screening.
- •11. Subjects will be willing to use the study products (comparator cigarette or THP product) and smoke only the products provided to them during clinical confinement, or to abstain from smoking if assigned to the cessation arm
排除标准
- •1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception (i.e., a condom with spermicide) in addition to a second highly effective method of contraception used by their female partners or to refrain from donating sperm from Admission (Day -1) until the end of the safety Follow-up period (5-7 days after Discharge)
- •2. Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (i.e. a condom with spermicide) from the time of signing the ICF until the end of the safety Follow-up period (5-7 days after Discharge)
- •3. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening and Admission. Any female subject who becomes pregnant during this study will be withdrawn
- •4. Subjects who have donated =400 mL of blood within 90 days prior to Admission; plasma in the 7 days prior to Admission; or platelets in the 6 weeks prior to Admission
- •5. Subjects who have an acute illness (e.g. upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to Admission
- •6. Subjects who have regularly used any nicotine or tobacco product other than commercially manufactured filter cigarettes within 14 days of Screening
- •7. Subjects who are self-reported non-inhalers (smokers who draw smoke from the cigarette into the mouth and throat but who do not inhale). Subjects who are observed as non-inhalers at Admission by the clinic staff will be excluded
- •8. Subjects who, prior to enrolment, are planning to quit smoking in the next 12 months. All subjects will be informed that they are free to quit smoking and withdraw from the study at any time. Any subject who decides to quit smoking will be directed to appropriate stop smoking services
- •9. Subjects who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to Screening, as determined by the PI
- •10. Subjects who have a positive urine drugs of abuse screen at Screening or Admission; or a positive alcohol breath test at Screening or Admission
- •11. Subjects who have serum hepatitis; are carriers of the hepatitis B surface antigen (HBsAg); are carriers of the hepatitis C antibody; have a positive result for the test for human immunodeficiency virus (HIV) antibodies; or have syphilis
- •12. Subjects who have used prescription or over-the-counter (OTC) bronchodilator medication (e.g. inhaled or oral ß-adrenergic agonists) to treat a chronic condition within the 12 months prior to Admission
- •13. Subjects who have received any medications or substances (other than tobacco) which interfere with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) within 14 days prior to Admission; or are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half-lives of the drug (whichever is longer) prior to Admission
- •14. Subjects who perform strenuous physical activity (exceeding the subject’s normal activity levels) within 7 days prior to Screening or Admission
- •15. Subjects who are unable to communicate effectively with the PI/study staff (i.e. language problem, poo
研究者
相似试验
已完成
不适用
A randomised multicentre open label blinded end point trial to compare the effects of spironolactone to chlortalidone on left ventricular mass in stage 2 and stage 3 chronic kidney diseaseTopic: Cardiovascular, Renal and UrogenitalSubtopic: Cardiovascular (all Subtopics), Renal and Urogenital (all Subtopics)Disease: Cardiovascular, RenalCirculatory SystemISRCTN94696478niversity of Birmingham (UK)154
已完成
不适用
Comparing the clinical effectiveness, acceptability and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosaAnorexia nervosaISRCTN10166784King's College London15
进行中（未招募）
不适用
The BASIL-3 Trial: Balloon vs. Stenting in Severe Ischaemia of the Leg-3Severe limb ischaemia due to femoro-popliteal diseaseCirculatory SystemPeripheral vascular disease, unspecifiedISRCTN14469736niversity of Birmingham481
已完成
3 期
A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B)Advanced pancreatic adenocarcinomaMalignant neoplasm of pancreasCancerISRCTN60516908niversity of Heidelberg (Germany)120
已完成
不适用
PD COMM StudyNervous System DiseasesParkinson's diseaseISRCTN12421382niversity of Birmingham388