Contact information
Type
Scientific
Primary contact
Dr Chris Proctor
ORCID ID
Contact details
Chief Scientific Officer
British American Tobacco (Investments) Ltd.
GR&D Centre
Regents Park Road
Southampton
SO15 8TL
United Kingdom
+44 (0)2380 588279
christopher_proctor@bat.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8201-712
Study information
Scientific title
A Randomised, Pharmacokinetic Study of Multiple Tobacco Products and an Over the Counter (OTC) Nicotine Product in Healthy Subjects
Acronym
Study hypothesis
The pharmacokinetic study will determine the plasma concentrations of nicotine at pre-determined time points, following single dose administration of different snus products, a cigarette and an OTC oral nicotine gum.
Ethics approval
The Central Ethical Review Board, Stockholm, Sweden approved on the 11th of November 2009 (ref: dnr Ö 20-2009)
Study design
Single dose open label randomised crossover controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a subject information sheet
Condition
Pharmacokinetic study with healthy volunteers
Intervention
The study will include five various tobacco related products (snus products, a cigarette) and an OTC oral nicotine gum. All subjects in the study would be daily snus users and occasional smokers.
Subjects will attend the study site for a pre-study screening visit within 30 days of entry into the study. Subjects who satisfy the inclusion/exclusion criteria will attend the study site six times to receive the test products. At each visit subjects will receive one of the products, assigned at random. Subjects will remain in the clinic for a period of 4 hours.
The following procedures will be performed during the study visits:
1. Blood sample collection to determine the CYP2A6 genotype (only at Visit 1) and nicotine concentrations in plasma.
2. Sensory questionnaire for evaluation of oral tobacco products.
Subjects will continue to attend clinic a minimum of every two days for product administration visits until they have received all products in the study. The Investigator will follow up all study Subjects to obtain information on any new adverse events and new/changes to concomitant medication within seven days of the last treatment visit. The study ensures all measures to comply with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines.
All Subjects will be provided Health advice and information on tobacco cessation help-lines
Principal Investigator:
Dr Ulf Malmqvist (M.D., Ph.D., Assoc. Prof.,)
Head of Department
Clinical Research and Trial Centre
Lund University Hospital
SE-221 85
LundSweden
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Nicotine in plasma
Secondary outcome measures
Sensory evaluation of oral tobacco products
Overall trial start date
20/01/2010
Overall trial end date
01/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Subjects will be males or non-pregnant, non-lactating females between 19 and 55 years of age inclusive. Female subjects must be postmenopausal (absence of menstrual discharge for at least two years and a serum FSH exceeding 30IU/L) or premenopausal/ perimenopausal with effective contraception (oral, injected or implanted contraceptives, intrauterine device or status after operative sterilisation).
2. Subjects must be in good health as determined by
2.1. medical history
2.2. 12-lead Electrocardiogram (ECG)
2.3. vital signs
2.4. physical examination
3. Subjects must have a body mass index (BMI) between 18 and 30 kg/m2 inclusive. Male subjects must have a weight between 50 and 110kg and female subjects between 40 and 90kg.
4. Subjects will have results of clinical laboratory evaluations within normal ranges (or if outside the normal ranges deemed as not clinically significant by the Investigator).
5. Subjects will have negative results for the drug screening test.
6. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
7. Subjects will be occasional smokers of 9-10mg ISO Tar cigarettes (on average, no more than 40 cigarettes per week) and daily snus users, who use snus products under their upper lip. If the subjects are pouched users they must use products of pouch weights 0.8g and above. They must have used snus and cigarettes for a minimum of six months prior to the start of the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
The study will be carried out at a single site in Sweden and is designed with 20 subjects.
Participant exclusion criteria
1. Subjects who have a history of, or clinically active significant, medical disorders incluing:
1.1. neurological
1.2. gastrointestinal
1.3. renal
1.4. hepatic
1.5. cardiovascular
1.6. psychiatric
1.7. respiratory
1.8. metabolic
1.9. endocrine
1.10. haematological disease
1.11. other major disorders
2. Subjects who have taken prescription or non-prescription drugs in the 14 days prior to the Screening Visit excluding oral contraceptives.
3. Subjects who have used any medication which interferes with the cyclo oxygenase pathway (anti-inflammatory drugs such as aspirin or ibuprofen) in the 14 days prior to the start of the study (Screening visit).
4. Subjects who have received any medications known to chronically alter nicotine absorption or elimination processes within 30 days of the first product administration.
5. Female subjects, who are pregnant or become pregnant during the course of the study.
6. Subjects who have lost or donated (more than 450ml) blood, plasma or platelets within the 3 months preceding the first product administration.
7. Subjects who are participating in another clinical research study.
8. Subjects who are currently trying to stop smoking or considering stopping in the next two months.
9. Subject who are currently trying to stop the use of snus or considering stopping in the next two months.
10. Subjects who in the opinion of the Investigator should not participate in the study.
11. Subjects who were unwilling or unable to abide by the study requirements.
Recruitment start date
20/01/2010
Recruitment end date
01/08/2010
Locations
Countries of recruitment
Sweden
Trial participating centre
Chief Scientific Officer
Southampton
SO15 8TL
United Kingdom
Sponsor information
Organisation
British American Tobacco (Investments) Ltd.
Sponsor details
GR&D Centre,Regents Park Road.
Southhampton
SO15 8TL
United Kingdom
+44 (0) 2380 793715
christopher_proctor@bat.com
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
British American Tobacco (Investments) Ltd. (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22585541
Publication citations
-
Results
Digard H, Proctor C, Kulasekaran A, Malmqvist U, Richter A, Determination of nicotine absorption from multiple tobacco products and nicotine gum., Nicotine Tob. Res., 2013, 15, 1, 255-261, doi: 10.1093/ntr/nts123.