Status:
COMPLETED
Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
CYP450 Phenotyping
Eligibility:
MALE
18-50 years
Phase:
NA
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 simultane...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03247699
Start Date
June 12 2017
End Date
July 30 2017
Last Update
September 21 2017
Active Locations (1)
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1
Ambulantes Studienzentrum, Universitätsspital Basel
Basel, Switzerland, 4031