<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/NCT03801733</url>
  </required_header>
  <id_info>
    <org_study_id>AKB 6548 CI 0030</org_study_id>
    <nct_id>NCT03801733</nct_id>
  </id_info>
  <brief_title>Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin</brief_title>
  <official_title>A Phase 1, Three-Part, Open-label Study in Healthy Adult Volunteers to Assess Vadadustat as a Perpetrator in Drug-Drug Interactions With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akebia Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akebia Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in&#xD;
      drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin and&#xD;
      simvastatin in healthy male and female subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in&#xD;
      drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and&#xD;
      simvastatin in healthy male and female subjects. Thirty-four (34) subjects will be enrolled&#xD;
      in Part 1 (rosuvastatin) and based on review of the PK and safety/tolerability data, a&#xD;
      decision will be made on whether to proceed with Part 2. Part 2 consists of 2 arms&#xD;
      (sulfasalazine and pravastatin). Twenty-six (26) subjects will be enrolled into each arm.&#xD;
      Part 3 consists of 2 arms (atorvastatin and simvastatin). Twenty-four (24) subjects will be&#xD;
      enrolled into each arm after enrollment in Part 2 is completed. Subjects will be in the study&#xD;
      for up to 72 days, including a 28-day screening period, 6-14 day in clinic period, and a&#xD;
      30-day follow up period post last dose. Blood samples for PK analysis will be collected at&#xD;
      pre-defined time points throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2018</start_date>
  <completion_date type="Actual">November 24, 2018</completion_date>
  <primary_completion_date type="Actual">November 24, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>This is a three-part sequential design study. Part 2 will be initiated based upon the outcome of Part 1 and Part 3 will be initiated after completion of Part 2.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of rosuvastatin, sulfasalazine, pravastatin and simvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin, sulfasalazine, pravastatin and simvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of rosuvastatin. sulfasalazine, pravastatin, atorvastatin and simvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under plasma concentration-time curve (AUCtau) of atorvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to maximum observed plasma concentration (Tmax) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination rate constant (Kel) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t½) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total body clearance (CL/F) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of extrapolated area under the curve from time t to infinity (%AUCextrap or Residual Area) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum observed plasma concentration (Tmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination rate constant (Kel) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t½) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve for a dosing interval (AUCtau) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum observed plasma concentration (Tmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of simvastatin metabolite</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of simvastatin metabolite</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of simvastatin metabolite</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum observed plasma concentration (Tmax) of simvastatin metabolite</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination rate constant (Kel) of simvastatin metabolite</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t½), of simvastatin metabolite</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reporting of treatment emergent adverse events (TEAE) as reported by the study subjects</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Drug Interaction Potentiation</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin, Vadadustat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 1: Subjects will receive rosuvastatin 20 mg alone, vadadustat 600 mg alone, followed by rosuvastatin 20 mg in combination with vadadustat 600 mg in a fixed-sequence dosing design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sulfasalazine. Pravastatin, Vadadustat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2, Arm 1: Subjects will receive sulfasalazine 500 mg alone followed by sulfasalazine 500 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.&#xD;
Part 2, Arm 2: Subjects will receive pravastatin 40 mg alone followed by pravastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin, Simvastatin, Vadadustat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 3, Arm 1: Subjects will receive atorvastatin 40 mg alone followed by atorvastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.&#xD;
Part 3, Arm 2: 24 subjects will receive simvastatin 40 mg alone followed by simvastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vadadustat</intervention_name>
    <description>Oral dose of 600 mg QD</description>
    <arm_group_label>Atorvastatin, Simvastatin, Vadadustat</arm_group_label>
    <arm_group_label>Rosuvastatin, Vadadustat</arm_group_label>
    <arm_group_label>Sulfasalazine. Pravastatin, Vadadustat</arm_group_label>
    <other_name>AKB 6548</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simvastatin</intervention_name>
    <description>Oral Simvastatin</description>
    <arm_group_label>Atorvastatin, Simvastatin, Vadadustat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>Oral Rosuvastatin</description>
    <arm_group_label>Rosuvastatin, Vadadustat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Oral Atorvastatin</description>
    <arm_group_label>Atorvastatin, Simvastatin, Vadadustat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pravastatin</intervention_name>
    <description>Oral Pravastatin</description>
    <arm_group_label>Sulfasalazine. Pravastatin, Vadadustat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sulfasalazine</intervention_name>
    <description>Oral Sulfasalazine</description>
    <arm_group_label>Sulfasalazine. Pravastatin, Vadadustat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Male or female between 18 and 55 years of age, inclusive, at time of informed&#xD;
             consent&#xD;
&#xD;
          -  Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for&#xD;
             females and 50 kg for males, inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past clinically significant history of cardiovascular, cerebrovascular,&#xD;
             pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic,&#xD;
             urologic, neurologic, dermatologic, psychiatric, or other major disease. History of&#xD;
             cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within&#xD;
             5 years prior to Screening; History of latent or active tuberculosis (TB).&#xD;
&#xD;
          -  Positive test results for human immunodeficiency virus (HIV) antibody; 12. Positive&#xD;
             test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus&#xD;
             antibody (HCVab) within 3 months prior to screening, or positive test results for&#xD;
             human immunodeficiency virus antibody (HIVab) at Screening&#xD;
&#xD;
          -  Taking any prescription medication or over the counter multi-vitamin supplement, or&#xD;
             any non-prescription products (including herbal-containing preparations but excluding&#xD;
             acetaminophen) within 14 days prior to Day -1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akebia Inc</last_name>
    <role>Study Director</role>
    <affiliation>Akebia Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>InVentiv Health Clinique Inc.</name>
      <address>
        <city>Québec City</city>
        <state>Quebec</state>
        <zip>G1P A02</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vadadustat</keyword>
  <keyword>Normal Healthy volunteers</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Rosuvastatin</keyword>
  <keyword>Sulfasalazine</keyword>
  <keyword>Pravastatin</keyword>
  <keyword>Atrovastatin</keyword>
  <keyword>Simvastatin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sulfasalazine</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
    <mesh_term>Simvastatin</mesh_term>
    <mesh_term>Pravastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03801733
org study id: AKB 6548 CI 0030
nct id: NCT03801733
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in
      drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin and
      simvastatin in healthy male and female subjects.
This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in
      drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and
      simvastatin in healthy male and female subjects. Thirty-four (34) subjects will be enrolled
      in Part 1 (rosuvastatin) and based on review of the PK and safety/tolerability data, a
      decision will be made on whether to proceed with Part 2. Part 2 consists of 2 arms
      (sulfasalazine and pravastatin). Twenty-six (26) subjects will be enrolled into each arm.
      Part 3 consists of 2 arms (atorvastatin and simvastatin). Twenty-four (24) subjects will be
      enrolled into each arm after enrollment in Part 2 is completed. Subjects will be in the study
      for up to 72 days, including a 28-day screening period, 6-14 day in clinic period, and a
      30-day follow up period post last dose. Blood samples for PK analysis will be collected at
      pre-defined time points throughout the study.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: This is a three-part sequential design study. Part 2 will be initiated based upon the outcome of Part 1 and Part 3 will be initiated after completion of Part 2.
primary purpose: Basic Science
masking: None (Open Label)
measure: Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of rosuvastatin, sulfasalazine, pravastatin and simvastatin
time frame: Up to 10 weeks
measure: Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin, sulfasalazine, pravastatin and simvastatin
time frame: Up to 10 weeks
measure: Maximum observed plasma concentration (Cmax) of rosuvastatin. sulfasalazine, pravastatin, atorvastatin and simvastatin
time frame: Up to 10 weeks
measure: Area under plasma concentration-time curve (AUCtau) of atorvastatin
time frame: Up to 10 weeks
measure: Time to maximum observed plasma concentration (Tmax) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
time frame: Up to 10 weeks
measure: Elimination rate constant (Kel) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
time frame: Up to 10 weeks
measure: Terminal half-life (t½) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
time frame: Up to 10 weeks
measure: Apparent total body clearance (CL/F) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
time frame: Up to 10 weeks
measure: Percentage of extrapolated area under the curve from time t to infinity (%AUCextrap or Residual Area) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin
time frame: Up to 10 weeks
measure: Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
time frame: Up to 10 weeks
measure: Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
time frame: Up to 10 weeks
measure: Maximum observed plasma concentration (Cmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
time frame: Up to 10 weeks
measure: Time to maximum observed plasma concentration (Tmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
time frame: Up to 10 weeks
measure: Elimination rate constant (Kel) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
time frame: Up to 10 weeks
measure: Terminal half-life (t½) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine
time frame: Up to 10 weeks
measure: Area under the plasma concentration-time curve for a dosing interval (AUCtau) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin
time frame: Up to 10 weeks
measure: Maximum observed plasma concentration (Cmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin
time frame: Up to 10 weeks
measure: Time to maximum observed plasma concentration (Tmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin
time frame: Up to 10 weeks
measure: Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of simvastatin metabolite
time frame: Up to 10 weeks
measure: Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of simvastatin metabolite
time frame: Up to 10 weeks
measure: Maximum observed plasma concentration (Cmax) of simvastatin metabolite
time frame: Up to 10 weeks
measure: Time to maximum observed plasma concentration (Tmax) of simvastatin metabolite
time frame: Up to 10 weeks
measure: Elimination rate constant (Kel) of simvastatin metabolite
time frame: Up to 10 weeks
measure: Terminal half-life (t½), of simvastatin metabolite
time frame: Up to 10 weeks
measure: Reporting of treatment emergent adverse events (TEAE) as reported by the study subjects
time frame: Up to 10 weeks
arm group label: Rosuvastatin, Vadadustat
arm group type: Experimental
description: Part 1: Subjects will receive rosuvastatin 20 mg alone, vadadustat 600 mg alone, followed by rosuvastatin 20 mg in combination with vadadustat 600 mg in a fixed-sequence dosing design.
arm group label: Sulfasalazine. Pravastatin, Vadadustat
arm group type: Experimental
description: Part 2, Arm 1: Subjects will receive sulfasalazine 500 mg alone followed by sulfasalazine 500 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.
Part 2, Arm 2: Subjects will receive pravastatin 40 mg alone followed by pravastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.
arm group label: Atorvastatin, Simvastatin, Vadadustat
arm group type: Experimental
description: Part 3, Arm 1: Subjects will receive atorvastatin 40 mg alone followed by atorvastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.
Part 3, Arm 2: 24 subjects will receive simvastatin 40 mg alone followed by simvastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.
intervention type: Drug
intervention name: Vadadustat
description: Oral dose of 600 mg QD
arm group label: Atorvastatin, Simvastatin, Vadadustat
arm group label: Rosuvastatin, Vadadustat
arm group label: Sulfasalazine. Pravastatin, Vadadustat
other name: AKB 6548
intervention type: Drug
intervention name: Simvastatin
description: Oral Simvastatin
arm group label: Atorvastatin, Simvastatin, Vadadustat
intervention type: Drug
intervention name: Rosuvastatin
description: Oral Rosuvastatin
arm group label: Rosuvastatin, Vadadustat
intervention type: Drug
intervention name: Atorvastatin
description: Oral Atorvastatin
arm group label: Atorvastatin, Simvastatin, Vadadustat
intervention type: Drug
intervention name: Pravastatin
description: Oral Pravastatin
arm group label: Sulfasalazine. Pravastatin, Vadadustat
intervention type: Drug
intervention name: Sulfasalazine
description: Oral Sulfasalazine
arm group label: Sulfasalazine. Pravastatin, Vadadustat
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Akebia Inc
role: Study Director
affiliation: Akebia Therapeutics
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Sulfasalazine
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium
mesh term: Simvastatin
mesh term: Pravastatin
sharing ipd: Undecided