Polychlorinated biphenyl pollution and drug metabolism Metabolic capacity of enzymes 2C9, 2C19, 2D6, 1A2, 2B6, 2A6 and 3A4 affected by genetic polymorphisms
Conditions
Interventions
Group 1: All subjects from the HELPcB-cohort will be administered the following six medications simultaneously on a one-time basis:
Caffeine Percoffedrinol 50mg p.o.
Metoprolol Metroprolol-Ratiopharm
Sponsors
Institut für Arbeits-Sozial- und Umweltmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Healthy adults (age = 18 years) from the HELPcB cohort and a nonexposed Control group Presence of written informed consent Weight 50-120 kg and BMI 18-33 kg/m2
Exclusion criteria
Exclusion criteria: Caffeine Hypersensitivity to the active substance or its components Metoprolol Hypersensitivity to the active substance or its components components decompensated or manifest heart failure Cardiogenic shock 2nd or 3rd degree AV block Sick sinus syndrome Sinuatrial block Bradycardia < 50 bpm Hypotension < 90 mmHg systolic Acidosis Severe pAVK untreated pheochromocytoma severe bronchial asthma Use of MAO inhibitors midazolam Hypersensitivity to the active substance or its components severe respiratory failure acute respiratory depression Torasemide Hypersensitivity to the active substance or its constituents components renal failure with anuria Coma or praecoma hepaticum Hypotension Hypovolaemia Hyponatraemia, hypokalaemia significant voiding dysfunction Bupropion Hypersensitivity to the active substance or its components Epilepsy tumours of the CNS Alcohol withdrawal or withdrawal from other drugs (e.g. benzodiazepines) severe liver cirrhosis Bulimia, anorexia nervosa Taking MAO inhibitors Omeprazole Hypersensitivity to the active ingredient or its or their components taking nelfinavir Pregnancy -drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is an open-label, non-randomised, pharmacokinetic and pharmacological trial. The test is not about the substances themselves (they have already been extensively tested in studies undertaken as part of the AMG studies), but about the biological properties of the individuals who will be participating in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The second objective is to determine the metabolic capacity based on the genetic polymorphisms of the CYP enzymes examined | — |
Countries
Germany
Contacts
Public ContactAndrea Kaifie-Pechmann
Institut für Arbeits-, Sozial- und Umweltmedizin
Outcome results
None listed