Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule

Study Overview
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Brief Summary
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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

Official Title
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Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule

Conditions
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CYP450 Phenotyping

Intervention / Treatment
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* Other: Basel phenotyping cocktail capsule
* Other: Basel phenotyping cocktail individual components


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Basel phenotyping cocktail capsule<br> | Other: Basel phenotyping cocktail capsule<br>* Oral intake of Basel phenotyping cocktail capsule and pharmacokinetics (PK) sampling<br>|
| Other: Basel phenotyping cocktail individual components<br> | Other: Basel phenotyping cocktail individual components<br>* Oral intake of Basel phenotyping cocktail individual components and PK sampling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration-time profile in plasma | Concentration-time Profiles assessed in Plasma over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios | -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 in capillary blood | Concentration-time Profile assessed in capillary blood over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios | -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 |