<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03247699</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01766</org_study_id>
    <nct_id>NCT03247699</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule</brief_title>
  <acronym>CombiCapsIII</acronym>
  <official_title>Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthy Subjects will receive treatment orally with 120-200ml tap water in fasted state.&#xD;
&#xD;
      Treatment in period A is the &quot;Basel phenotyping cocktail&quot; capsule. Treatment in period B&#xD;
      consists of simultaneous intake of isolated formulations. In both study arms peripheral&#xD;
      venous and capillary blood (DBS) samples will be drawn&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">July 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration-time profile in plasma</measure>
    <time_frame>-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</time_frame>
    <description>Concentration-time Profiles assessed in Plasma over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration-time profile in capillary blood</measure>
    <time_frame>-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</time_frame>
    <description>Concentration-time Profile assessed in capillary blood over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>CYP450 Phenotyping</condition>
  <arm_group>
    <arm_group_label>&quot;Basel phenotyping cocktail&quot; capsule</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Basel phenotyping cocktail&quot; individual components</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>&quot;Basel phenotyping cocktail&quot; capsule</intervention_name>
    <description>Oral intake of &quot;Basel phenotyping cocktail&quot; capsule and pharmacokinetics (PK) sampling</description>
    <arm_group_label>&quot;Basel phenotyping cocktail&quot; capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>&quot;Basel phenotyping cocktail&quot; individual components</intervention_name>
    <description>Oral intake of &quot;Basel phenotyping cocktail&quot; individual components and PK sampling</description>
    <arm_group_label>&quot;Basel phenotyping cocktail&quot; individual components</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-50 years old&#xD;
&#xD;
          -  Caucasian male volunteers&#xD;
&#xD;
          -  Body mass index (BMI)18-30kg/m2,weight more than 50kg&#xD;
&#xD;
          -  Full mental and legal capacity&#xD;
&#xD;
          -  Signed informed consent prior to any study related procedure&#xD;
&#xD;
          -  Ability to communicate in German or English, sufficient to comprehend and adhere to&#xD;
             study protocol&#xD;
&#xD;
          -  Systolic blood pressure (SBP) 100-145mmHg, diastolic blood pressure (DBP) 50-90mmHg&#xD;
             and heart rate (HR) 45-90bpm (inclusive), measured on the leading arm*, after 5min in&#xD;
             the supine position at screening Normal physical examination, vital signs, laboratory&#xD;
             workup, and electrocardiogram (ECG)&#xD;
&#xD;
          -  Hematology and clinical chemistry results not deviating from the normal range to a&#xD;
             clinically relevant extent at screening&#xD;
&#xD;
          -  No other conditions or circumstances that might interfere with compliance with study&#xD;
             protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to any excipients of the drug formulations.&#xD;
&#xD;
          -  History or clinical evidence of any disease and/or existence of any surgical or&#xD;
             medical condition, which might interfere with the absorption, distribution, metabolism&#xD;
             or excretion of the study drugs, or which might increase the risk for toxicity.&#xD;
&#xD;
          -  History or presence of smoking (within the last 3months prior to screening) or alcohol&#xD;
             or drug abuse&#xD;
&#xD;
          -  Intake of prescribed or otc medications, herbal preparations, and / or vitamin/dietary&#xD;
             supplements within 2weeks prior to the intended start of study.&#xD;
&#xD;
          -  Excessive caffeine consumption, defined as &gt;800 mg per day at Screening Intake of food&#xD;
             products (immediately before or during study) known to be inducers or inhibitors of&#xD;
             CYP450&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan Krähenbühl, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsspital Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ambulantes Studienzentrum, Universitätsspital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Results of Trial will be published in a peer reviewed Journal</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03247699
org study id: 2016-01766
nct id: NCT03247699
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Concentration-time profile in plasma
time frame: -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
description: Concentration-time Profiles assessed in Plasma over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios
measure: Concentration-time profile in capillary blood
time frame: -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
description: Concentration-time Profile assessed in capillary blood over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios
arm group label: "Basel phenotyping cocktail" capsule
arm group type: Other
arm group label: "Basel phenotyping cocktail" individual components
arm group type: Other
intervention type: Other
intervention name: "Basel phenotyping cocktail" capsule
description: Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling
arm group label: "Basel phenotyping cocktail" capsule
intervention type: Other
intervention name: "Basel phenotyping cocktail" individual components
description: Oral intake of "Basel phenotyping cocktail" individual components and PK sampling
arm group label: "Basel phenotyping cocktail" individual components
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephan Krähenbühl, MD PhD
role: Principal Investigator
affiliation: Universitätsspital Basel, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No
ipd description: Results of Trial will be published in a peer reviewed Journal