<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/NCT01704638</url>
  </required_header>
  <id_info>
    <org_study_id>fluvoxaminedigoxin</org_study_id>
    <nct_id>NCT01704638</nct_id>
  </id_info>
  <brief_title>Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will compare plasma kinetics of two marker drugs in individuals with&#xD;
      different genetic variations in the MDR1-gene. The hypothesis is that one group will have&#xD;
      higher exposure than the other.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2008</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of fluvoxamine and of digoxin</measure>
    <time_frame>2 days for fluvoxamine and 2 days for digoxin. Washout period of at least 1 week between the both parts. Total study time maximum 4 weeks.</time_frame>
    <description>The participants are administered a single dose of fluvoxamine or digoxin. Plasma kinetics of fluvoxamine are followed for 36 hours. Plasma kinetics of digoxin are followed for 48 hours. There is a washout period between the both parts.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>2677TT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plasma kinetics of fluvoxamine and digoxin in this genotype</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2677GG</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>plasma kinetics of fluvoxamine and digoxin in this genotype</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluvoxamine</intervention_name>
    <arm_group_label>2677GG</arm_group_label>
    <arm_group_label>2677TT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Digoxin</intervention_name>
    <arm_group_label>2677GG</arm_group_label>
    <arm_group_label>2677TT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Healthy volunteer ≥ 18 years of age&#xD;
&#xD;
          -  Normal kidney function as measured by GFR according to Cockroft-Gault (70-120 ml/min)&#xD;
&#xD;
          -  Normal P-potassiumvalue (3,6-4,6 mmol/L)&#xD;
&#xD;
          -  HF&gt;50 and no AV-block on resting ECG. No other significant abnormalities as judged by&#xD;
             the investigator.&#xD;
&#xD;
          -  Subject giving written informed consent&#xD;
&#xD;
          -  Subject capable of understanding instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Pregnancy&#xD;
&#xD;
          -  Ongoing infection&#xD;
&#xD;
          -  Intake of medication, including natural remedies (for example St John´s wort), within&#xD;
             one month prior to starting study except for paracetamol.&#xD;
&#xD;
          -  Active drug or alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CPTU</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>August 31, 2015</last_update_submitted>
  <last_update_submitted_qc>August 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Erik Sparve</investigator_full_name>
    <investigator_title>MD, specialist in clinical pharmacology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digoxin</mesh_term>
    <mesh_term>Fluvoxamine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01704638
org study id: fluvoxaminedigoxin
nct id: NCT01704638
lead sponsor: 
has dmc: Yes
The investigators will compare plasma kinetics of two marker drugs in individuals with
      different genetic variations in the MDR1-gene. The hypothesis is that one group will have
      higher exposure than the other.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Cmax of fluvoxamine and of digoxin
time frame: 2 days for fluvoxamine and 2 days for digoxin. Washout period of at least 1 week between the both parts. Total study time maximum 4 weeks.
description: The participants are administered a single dose of fluvoxamine or digoxin. Plasma kinetics of fluvoxamine are followed for 36 hours. Plasma kinetics of digoxin are followed for 48 hours. There is a washout period between the both parts.
arm group label: 2677TT
arm group type: Experimental
description: Plasma kinetics of fluvoxamine and digoxin in this genotype
arm group label: 2677GG
arm group type: Other
description: plasma kinetics of fluvoxamine and digoxin in this genotype
intervention type: Drug
intervention name: fluvoxamine
arm group label: 2677GG
arm group label: 2677TT
intervention type: Drug
intervention name: Digoxin
arm group label: 2677GG
arm group label: 2677TT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Erik Sparve
investigator title: MD, specialist in clinical pharmacology
mesh term: Depression
mesh term: Digoxin
mesh term: Fluvoxamine