<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/NCT01674192</url>
  </required_header>
  <id_info>
    <org_study_id>PRU-USA-6</org_study_id>
    <nct_id>NCT01674192</nct_id>
  </id_info>
  <brief_title>Prucalopride Subjects With Renal Impairment</brief_title>
  <official_title>Single Dose Pharmacokinetic Trial of Oral Prucalopride (R093877) in Subjects With Mild, Moderate and Severe Renal Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Movetis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Movetis</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of&#xD;
      prucalopride in subjects with various degrees of renal impairment compared with normal renal&#xD;
      function and to monitor the safety profile of prucalopride in subjects with renal impairment.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally&#xD;
      impaired subjects compared with the normal population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-centre, open label, single-dose, pharmacokinetic trial with prucalopride in&#xD;
      subjects with varying degrees of renal impairment. Subjects were classified into one of four&#xD;
      renal function groups, as defined by a 24-hour creatinine clearance determination (CRCL)&#xD;
      obtained within 2 weeks before trial entry. Each subject was administered a single 2mg oral&#xD;
      dose of prucalopride. Plasma samples and complete urine collections were obtained from 0&#xD;
      through 120 h (6 days) after dosing to characterize the pharmacokinetics of prucalopride.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 1997</start_date>
  <completion_date type="Actual">August 1999</completion_date>
  <primary_completion_date type="Actual">August 1999</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To characterize the Pharmacokinetic profile of prucalopride in subjects with various degrees of renal impairement</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary efficacy variables: to evaluate the safety and tolerability of prucalopride in subjects with various degrees of renal impairement</measure>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>prucalopride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose of 2 mg prucalopride</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prucalopride</intervention_name>
    <description>single dose of 2 mg prucalopride</description>
    <arm_group_label>prucalopride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All subjects had to meet the following inclusion criteria:&#xD;
&#xD;
          -  Between the ages of 18 and 75 years, inclusive;&#xD;
&#xD;
          -  Males or females. Females were to be of non-childbearing potential.&#xD;
&#xD;
        Normal subjects had to meet the following additional inclusion criteria:&#xD;
&#xD;
          -  Demographically comparable to the subjects with renal impairment, within 30% of mean&#xD;
             weight and height and 10% of the mean age;&#xD;
&#xD;
          -  Physical examination, clinical laboratory results, and 12-lead ECG within normal&#xD;
             limits at screening;&#xD;
&#xD;
          -  No intake of medication, including over-the-counter medication, during a pre-trial&#xD;
             7-day drug-free washout period;&#xD;
&#xD;
        Subjects with renal impairment had to meet the following additional inclusion criteria:&#xD;
&#xD;
          -  Stable severity of renal disease;&#xD;
&#xD;
          -  Concomitant medications to treat underlying disease states or medical conditions&#xD;
             related to renal insufficiency were allowed;&#xD;
&#xD;
          -  Stable dose of medication and/or treatment regimen from 2 months prior to and during&#xD;
             the trial;&#xD;
&#xD;
          -  Subjects with stable cardiovascular disease could be enrolled, provided that the&#xD;
             investigator felt their condition would not interfere with the results of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All subjects who met any of the following criteria were excluded from the trial:&#xD;
&#xD;
          -  History of hypersensitivity to prucalopride or inactive ingredients in the&#xD;
             prucalopride capsule or to related prokinetic compounds;&#xD;
&#xD;
          -  Use of any other investigational drug within 30 days prior to signing the consent or&#xD;
             intention to take any investigational drug during the trial;&#xD;
&#xD;
          -  History of significant blood loss, or blood plasma donation (500mL) within the last 30&#xD;
             days;&#xD;
&#xD;
          -  Pregnancy or breast feeding;&#xD;
&#xD;
          -  Gastrointestinal (GI) surgery within 3 months, or history of major GI surgery with&#xD;
             potential compromise of drug absorption or metabolism;&#xD;
&#xD;
        Normal subjects who met any of the following criteria were excluded from the trial:&#xD;
&#xD;
          -  Any abnormal medical history, physical examination, ECG, or laboratory results;&#xD;
&#xD;
          -  Use of medications 7 days prior to and during the trial.&#xD;
&#xD;
          -  Subjects with renal impairment who met any of the following criteria were excluded&#xD;
             from the trial.&#xD;
&#xD;
          -  Any abnormality in medical history, physical examination, ECG, or laboratory results&#xD;
             that, in the opinion of the investigator, might affect the safety of the subject;&#xD;
&#xD;
          -  History of uric acid stone disease, uricosuria, or gout, or current hyperuricemia;&#xD;
&#xD;
          -  Renal transplants, lupus erythematosus, or renal carcinoma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>W. Smith, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>New Orleans Center for Clinical Research, 2820 Canal Street, New Orleans, LA 70119</affiliation>
  </overall_official>
  <verification_date>June 2012</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prucalopride</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/NCT01674192
org study id: PRU-USA-6
nct id: NCT01674192
lead sponsor: 
The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of
      prucalopride in subjects with various degrees of renal impairment compared with normal renal
      function and to monitor the safety profile of prucalopride in subjects with renal impairment.

      Hypothesis:

      Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally
      impaired subjects compared with the normal population.
This is a single-centre, open label, single-dose, pharmacokinetic trial with prucalopride in
      subjects with varying degrees of renal impairment. Subjects were classified into one of four
      renal function groups, as defined by a 24-hour creatinine clearance determination (CRCL)
      obtained within 2 weeks before trial entry. Each subject was administered a single 2mg oral
      dose of prucalopride. Plasma samples and complete urine collections were obtained from 0
      through 120 h (6 days) after dosing to characterize the pharmacokinetics of prucalopride.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To characterize the Pharmacokinetic profile of prucalopride in subjects with various degrees of renal impairement
measure: Secondary efficacy variables: to evaluate the safety and tolerability of prucalopride in subjects with various degrees of renal impairement
arm group label: prucalopride
arm group type: Experimental
description: single dose of 2 mg prucalopride
intervention type: Drug
intervention name: prucalopride
description: single dose of 2 mg prucalopride
arm group label: prucalopride
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: W. Smith, M.D.
role: Principal Investigator
affiliation: New Orleans Center for Clinical Research, 2820 Canal Street, New Orleans, LA 70119
responsible party type: Sponsor
mesh term: Constipation
mesh term: Prucalopride