CYP450 Phenotyping
Conditions
Brief summary
Healthy Subjects will receive treatment orally with 120-200ml tap water in fasted state. Treatment in period A is the Basel phenotyping cocktail capsule. Treatment in period B consists of simultaneous intake of isolated formulations. In both study arms peripheral venous and capillary blood (DBS) samples will be drawn
Interventions
Oral intake of Basel phenotyping cocktail capsule and pharmacokinetics (PK) sampling
OTHERBasel phenotyping cocktail individual components
Oral intake of Basel phenotyping cocktail individual components and PK sampling
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-50 years old * Caucasian male volunteers * Body mass index (BMI)18-30kg/m2,weight more than 50kg * Full mental and legal capacity * Signed informed consent prior to any study related procedure * Ability to communicate in German or English, sufficient to comprehend and adhere to study protocol * Systolic blood pressure (SBP) 100-145mmHg, diastolic blood pressure (DBP) 50-90mmHg and heart rate (HR) 45-90bpm (inclusive), measured on the leading arm\*, after 5min in the supine position at screening Normal physical examination, vital signs, laboratory workup, and electrocardiogram (ECG) * Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening * No other conditions or circumstances that might interfere with compliance with study protocol
Exclusion criteria
* Known hypersensitivity to any excipients of the drug formulations. * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity. * History or presence of smoking (within the last 3months prior to screening) or alcohol or drug abuse * Intake of prescribed or otc medications, herbal preparations, and / or vitamin/dietary supplements within 2weeks prior to the intended start of study. * Excessive caffeine consumption, defined as \>800 mg per day at Screening Intake of food products (immediately before or during study) known to be inducers or inhibitors of CYP450
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration-time profile in plasma | -5 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours | Concentration-time Profiles assessed in Plasma over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios |
| Concentration-time profile in capillary blood | -5 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours | Concentration-time Profile assessed in capillary blood over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios |
Countries
Switzerland
Outcome results
None listed