Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule
NCT ID: NCT03247699
Last Updated: 2017-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2017-06-12
2017-07-30
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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"Basel phenotyping cocktail" capsule
"Basel phenotyping cocktail" capsule
Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling
"Basel phenotyping cocktail" individual components
"Basel phenotyping cocktail" individual components
Oral intake of "Basel phenotyping cocktail" individual components and PK sampling
Interventions
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"Basel phenotyping cocktail" capsule
Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling
"Basel phenotyping cocktail" individual components
Oral intake of "Basel phenotyping cocktail" individual components and PK sampling
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
MALE
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Stephan Krähenbühl, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Basel, Switzerland
Locations
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Ambulantes Studienzentrum, Universitätsspital Basel
Basel, , Switzerland
Countries
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Other Identifiers
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2016-01766
Identifier Type: -
Identifier Source: org_study_id