Clinical trial NCT03247699: Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule
Official title: Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CYP450 Phenotyping
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Concentration-time profile in plasma
timeFrame: -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
measure: Concentration-time profile in capillary blood
timeFrame: -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
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Ambulantes Studienzentrum, Universitätsspital Basel
Study officials:
affiliation: Universitätsspital Basel, Switzerland
name: Stephan Krähenbühl, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: