This study involves healthy adult never smokers to obtain information on biomarkers of exposure to eugenol in urine Not Applicable
Conditions
Interventions
The clinical study will be conducted in compliance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice (GCP). Particip
Sponsors
British American Tobacco (Investments) Ltd. (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged between = 18 and = 50 years 2. Body Mass Index (BMI) = 18 and = 30 kg/m² inclusive 3. Provide written informed consent 4. Subjects must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator 5. Non-smokers 6. Healthy male volunteers, as judged by a medical history, concomitant medication, physical examination, vital signs, 12-lead ECG and laboratory safety tests 7. HIV and Hepatitis B and C tests, taken within 21 days prior to the start of the study, must be negative 8. Willingness to avoid eugenol-containing foods (e.g., cola, curry, clove, cinnamon, nutmeg, basil, dill, star anise) and dental surgery products such as mouthwash 48 h prior to study start 9. Willingness to comply with specific diet restrictions during study course: eugenol-free diet (no cola, curry, clove, cinnamon, nutmeg, basil, dill, star anise) and eugenol-rich diet (cinnamon, curry, clove, bay leaves, turmeric, pumpkin bread, cola-type drinks and coffee) 10. No allergy against eugenol or against eugenol-containing food/spices like cola, curry, clove, cinnamon, nutmeg, basil, dill and star anise 11. Subject understands the study procedures and signs forms providing informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. History or presence of significant cardiovascular disease 2. Known allergy against any food 3. Existing gastrointestinal disorder 4. History of alcohol or drug abuse or a positive breath or urine test, respectively at screening and on Day 1 5. Subjects should not drink methylxanthine- and caffeine-containing drinks (e.g., cola, coffee) during the wash-out and eugenol-free diet phase 6. Clinically significant illness within 14 days prior to start of study 7. Participation in a clinical trial with an investigational drug within 8 weeks prior to the first dosing 8. Use of any prescription drug within 2 weeks before Day 1 and use of any OTC drug within 3 days before Day 1 9. Diet, which in the opinion of the Investigator, deviates from a normal diet (e.g., vegetarians may be acceptable, vegans are not acceptable) 10. Subjects who have urinary cotinine levels similar to that of smokers (=30 ng/mL, levels = 2 according to the NicAlert™ Scale)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify via GC-MS/MS method 'total' eugenol biomarker in 24 hours urine after treatment with glucuronidase/sulfatases | — |
Countries
Germany
Outcome results
None listed