In vivo characterisation of cytochrome p450 enzymesin the presence of increased internal PCB exposure
- Conditions
- Polychlorinated biphenyl pollution and drug metabolismMetabolic capacity of enzymes 2C9, 2C19, 2D6, 1A2, 2B6, 2A6 and 3A4 affected by genetic polymorphisms
- Registration Number
- DRKS00028922
- Lead Sponsor
- Institut für Arbeits-Sozial- und Umweltmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 35
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The second objective is to determine the metabolic capacity based on the genetic polymorphisms of the CYP enzymes examined