Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule (CombiCapsIII)

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

Study Overview

• Status: Completed
• Conditions: CYP450 Phenotyping
• Intervention / Treatment: Other: "Basel phenotyping cocktail" capsule; Other: "Basel phenotyping cocktail" individual components

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Ambulantes Studienzentrum, Universitätsspital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: "Basel phenotyping cocktail" capsule	Other: "Basel phenotyping cocktail" capsule; Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling
OTHER: "Basel phenotyping cocktail" individual components	Other: "Basel phenotyping cocktail" individual components; Oral intake of "Basel phenotyping cocktail" individual components and PK sampling

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Stephan Krähenbühl, MD PhD, Universitätsspital Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2017
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 30, 2017

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (ACTUAL): August 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2016-01766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results of Trial will be published in a peer reviewed Journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No