Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule

Not Applicable

Completed

• Conditions: CYP450 Phenotyping
• Interventions: Other: "Basel phenotyping cocktail" individual components; Other: "Basel phenotyping cocktail" capsule

• Registration Number: NCT03247699
• Lead Sponsor: University Hospital, Basel, Switzerland

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-12
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-30
• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-14
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
"Basel phenotyping cocktail" individual components	"Basel phenotyping cocktail" individual components	-
"Basel phenotyping cocktail" capsule	"Basel phenotyping cocktail" capsule	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ambulantes Studienzentrum, Universitätsspital Basel; 🇨🇭 Basel, Switzerland