Drug metabolism related to obesity
- Conditions
- MedDRA version: 19.1Level: LLTClassification code 10029885Term: Obesity, unspecifiedSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2014-004554-34-DK
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Obese children (BMI = 99 % percentile)
•Healthy non-obese children (BMI= 90 % percentile)
•Age 11-18 years
•Both genders (block stratified)
•Postmenarche (females)
•Written informed consent from both parents (age<18)
Females included will be post menarche (Tanner stage 4) in order to avoid bias, as maturation of CYP1A2 activity mirrors pubertal growth, which peaks early in females.
Are the trial subjects under 18? yes
Number of subjects for this age range: 68
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
•Acute or chronic Liver diseases
•Other chronic diseases, except from allergic rhinitis, rash etc.
•Intake of drugs known to induce of inhibit CYP2E1-, CYP3A4 and/or CYP1A2, including paracetamol, ciprofloxacin, azithromycin, ketoconazol, estradiol etc.
•Citrus fruit
•Alcohol intake within minimum 72 hours
•Caffeine (Coca Cola©, coffee and tea) intake 48 h prior to administration of the caffeine-probe
•Smoking 96 hours prior to administration of the caffeine-probe, screening test will be performed (nicotine metabolite: cotinine)
•Kidney disease and dialysis
•Pregnancy (test will be performed)
•Known hypersensitivity to chlorzoxazone, midazolam or caffeine
•vigorous exercise 24 hours before administration
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method