ISRCTN81286286
Completed
未知
A single-blinded, single-centre, controlled study in healthy adult smokers to identify the effects of reduced toxicant prototype (RTP) cigarettes on biomarkers of exposure and of biological effect versus commercial cigarettes.
British American Tobacco (Investments) Ltd (UK)0 sites260 target enrollmentMarch 19, 2012
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Smoking
- Sponsor
- British American Tobacco (Investments) Ltd (UK)
- Enrollment
- 260
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Universal Inclusion Criteria
- •1\. Participants may be of either sex and of any ethnic origin
- •2\. Male and female participants must weigh at least 52 kg and 45 kg, respectively, and fall within the normal range according to accepted normal values of Body Mass Index (BMI) 18\.5\-30\.0 kg/m2 (inclusive)
- •3\. Participants must have no clinically significant abnormal findings, as judged by the project investigator (PI) or his appropriately qualified designee, on the physical examination, ECG, clinical laboratory test results, lung function tests or medical history during screening.
- •4\. Participants must give voluntary written informed consent to participate in this study
- •5\. Participants must be willing to refrain from consuming alcohol within 72 hours prior to the first day of each in\-clinic evaluation visit
- •6\. Participants must be willing to refrain from consuming grilled, fried or barbequed food and avoid being in the presence of the cooking of grilled, fried or barbequed food for 48 hours prior to the first day of each in\-clinic evaluation visit
- •7\. Female participants must not be pregnant or breastfeeding at screening and at check\-in of each in\-clinic evaluation period and be using a reliable method of contraception as per definition of Note 3 of ICH M3 Guideline
- •Inclusion Criteria for Smoking Groups:
- •1\. Participants must be aged 23 to 55 years of age (inclusive)
Exclusion Criteria
- •Universal Exclusion Criteria
- •1\. Participants may be excluded from the study if there is evidence of any of the following criteria at Screening, or at any time during the study as appropriate
- •2\. Participants who have clinically relevant gastrointestinal, renal, hepatic, neurologic, haematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition that, in the opinion of the PI or his appropriately qualified designee, would jeopardize the safety of the participant or impact the validity of the study results.
- •3\. Participants who have clinically relevant abnormal findings on the physical examination, medical history, or clinical laboratory results unless deemed not clinically significant by the PI or his appropriately qualified designee
- •4\. Participants who have participated in a previous clinical trial within 30 days prior to Day 1
- •5\. Participants who have donated or lost 400 mL of blood or more within 90 days prior to Day 1
- •6\. Participants who have donated plasma within 7 days prior to Day 1
- •7\. Participants who have an acute illness (e.g. upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to Day 1
- •8\. Participants who regularly use any nicotine or tobacco products other than commercially manufactured filter cigarettes
- •9\. Participants who are self\-reported non\-inhalers (smokers who draw smoke from the cigarette into the mouth and throat but do not inhale). Participants who are observed as non\-inhalers on Day 12 by the clinic staff will be excluded
Outcomes
Primary Outcomes
Not specified
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