<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/NCT02228733</url>
  </required_header>
  <id_info>
    <org_study_id>KBP5074-1-001</org_study_id>
    <nct_id>NCT02228733</nct_id>
  </id_info>
  <brief_title>Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074</brief_title>
  <official_title>An Open-Label, Parallel-Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-5074 Following Oral Administration and With a Food Effect Panel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KBP Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KBP Biosciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This single ascending dose (SAD) study in healthy subjects will evaluate the safety,&#xD;
      tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and&#xD;
      urine albumin levels) relationships will be explored to support the selection of dosing&#xD;
      regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the&#xD;
      efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of&#xD;
      nephropathy as well as control hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, parallel-group, dose-escalation study to evaluate the safety,&#xD;
      tolerability and pharmacokinetics of KBP-5074 following a single dose administration of&#xD;
      KBP-5074 with and without food. The study includes 2 parts.&#xD;
&#xD;
      Part 1: Pharmacokinetics from each dose cohort will be characterized before initiation of&#xD;
      dosing in the subsequent cohorts. Eight subjects in each dose cohort will receive active&#xD;
      drug. The total number of cohorts will be up to 5. Extensive PK samplings will be collected&#xD;
      prior to and following administration of single dose of KBP-5074.&#xD;
&#xD;
      Part 2: A separate panel of 6 subjects will receive a single dose of KBP-5074 under fed&#xD;
      conditions. Extensive PK samplings will be collected prior to and following administration of&#xD;
      single dose of KBP-5074 under fed conditions.&#xD;
&#xD;
      Serum and plasma samples for pharmacodynamic markers (plasma aldosterone and serum potassium&#xD;
      levels) will be collected at pre-dose and postdose in both Part 1 and Part 2.&#xD;
&#xD;
      The urine samples will be also used for quantitative determination of urinary albumin in both&#xD;
      Part 1 and Part 2.&#xD;
&#xD;
      Safety assessments will include monitoring of adverse events (AEs), vital signs (blood&#xD;
      pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings,&#xD;
      12-lead electrocardiograms (ECGs), and physical examination findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The safety and tolerability (i.e., number of participatns with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations): predose and postdose</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effect of food on Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The plasma aldosterone, serum potassium and urine albumin levels: predose and postdose</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>KBP-5074: Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Volunteers will receive one dose of KBP-5074</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KBP-5074: Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Volunteers will receive one dose of KBP-5074</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KBP-5074: Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Volunteers will receive one dose of KBP-5074</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KBP-5074: Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Volunteers will receive one dose of KBP-5074</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KBP-5074: Cohort 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Volunteers will receive one dose of KBP-5074</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KBP-5074: Fed Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Volunteers will receive one dose of KBP-5074</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KBP-5074</intervention_name>
    <description>Comparisons of different doses of study drug</description>
    <arm_group_label>KBP-5074: Cohort 1</arm_group_label>
    <arm_group_label>KBP-5074: Cohort 2</arm_group_label>
    <arm_group_label>KBP-5074: Cohort 3</arm_group_label>
    <arm_group_label>KBP-5074: Cohort 4</arm_group_label>
    <arm_group_label>KBP-5074: Cohort 5</arm_group_label>
    <arm_group_label>KBP-5074: Fed Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2, no significant medical history, normal&#xD;
             renal function and in good general health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,&#xD;
             endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,&#xD;
             immunologic, lipid metabolism disorders, or drug hypersensitivity; A history of&#xD;
             prescription drug abuse, or illicit drug use within 6 months prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 11, 2015</last_update_submitted>
  <last_update_submitted_qc>August 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02228733
org study id: KBP5074-1-001
nct id: NCT02228733
lead sponsor: 
has dmc: Yes
This single ascending dose (SAD) study in healthy subjects will evaluate the safety,
      tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and
      urine albumin levels) relationships will be explored to support the selection of dosing
      regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the
      efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of
      nephropathy as well as control hypertension.
This is an open-label, parallel-group, dose-escalation study to evaluate the safety,
      tolerability and pharmacokinetics of KBP-5074 following a single dose administration of
      KBP-5074 with and without food. The study includes 2 parts.

      Part 1: Pharmacokinetics from each dose cohort will be characterized before initiation of
      dosing in the subsequent cohorts. Eight subjects in each dose cohort will receive active
      drug. The total number of cohorts will be up to 5. Extensive PK samplings will be collected
      prior to and following administration of single dose of KBP-5074.

      Part 2: A separate panel of 6 subjects will receive a single dose of KBP-5074 under fed
      conditions. Extensive PK samplings will be collected prior to and following administration of
      single dose of KBP-5074 under fed conditions.

      Serum and plasma samples for pharmacodynamic markers (plasma aldosterone and serum potassium
      levels) will be collected at pre-dose and postdose in both Part 1 and Part 2.

      The urine samples will be also used for quantitative determination of urinary albumin in both
      Part 1 and Part 2.

      Safety assessments will include monitoring of adverse events (AEs), vital signs (blood
      pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings,
      12-lead electrocardiograms (ECGs), and physical examination findings.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The safety and tolerability (i.e., number of participatns with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations): predose and postdose
time frame: 14 days
measure: Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose
time frame: 14 days
measure: The effect of food on Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose
time frame: 14 days
measure: The plasma aldosterone, serum potassium and urine albumin levels: predose and postdose
time frame: 14 days
arm group label: KBP-5074: Cohort 1
arm group type: Experimental
description: Healthy Volunteers will receive one dose of KBP-5074
arm group label: KBP-5074: Cohort 2
arm group type: Experimental
description: Healthy Volunteers will receive one dose of KBP-5074
arm group label: KBP-5074: Cohort 3
arm group type: Experimental
description: Healthy Volunteers will receive one dose of KBP-5074
arm group label: KBP-5074: Cohort 4
arm group type: Experimental
description: Healthy Volunteers will receive one dose of KBP-5074
arm group label: KBP-5074: Cohort 5
arm group type: Experimental
description: Healthy Volunteers will receive one dose of KBP-5074
arm group label: KBP-5074: Fed Group
arm group type: Experimental
description: Healthy Volunteers will receive one dose of KBP-5074
intervention type: Drug
intervention name: KBP-5074
description: Comparisons of different doses of study drug
arm group label: KBP-5074: Cohort 1
arm group label: KBP-5074: Cohort 2
arm group label: KBP-5074: Cohort 3
arm group label: KBP-5074: Cohort 4
arm group label: KBP-5074: Cohort 5
arm group label: KBP-5074: Fed Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
country: United States
responsible party type: Sponsor