<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/NCT01663389</url>
  </required_header>
  <id_info>
    <org_study_id>112167</org_study_id>
    <nct_id>NCT01663389</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 After an Intravenous and an Oral Dose</brief_title>
  <official_title>An Open Label, Non-Randomized, Single Dose, Two Period, Cross-Over, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 Administered as a Single Intravenous and Single Oral Dose to Healthy Adult Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study.&#xD;
      This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion,&#xD;
      and pharmacokinetics of GSK1322322 in 6 healthy adult male subjects through the sampling of&#xD;
      blood, urine, and feces.&#xD;
&#xD;
      Each subject will participate in the study for approximately 7 to 8 weeks i.e., 30 day&#xD;
      screening period, two dosing periods (approximately 8 days each) and a follow up visit.&#xD;
&#xD;
      The subjects will be admitted to the clinical unit on Day 1 of the first treatment period and&#xD;
      remain in the unit for up to approximately 16 days through the end of the second treatment&#xD;
      period.&#xD;
&#xD;
      On Day 1 of Period 1, each subject will receive 14C radiolabeled GSK1322322 as a single&#xD;
      therapeutic intravenous (IV) dose (1000 milligrams [mg]). When the total radioactivity is &lt;1%&#xD;
      of the administered dose in all subjects, Period 2 dosing will begin (approximately 8 days&#xD;
      after the IV dose). On Day 1 of Period 2, each subject will receive single therapeutic oral&#xD;
      solution dose (1200 mg). Blood, urine, bile and fecal samples will be collected during both&#xD;
      the periods. The subject may be discharged from the unit as early as Day 8 of Period 2.&#xD;
      Subjects will visit the study unit for the follow-up visit 7 to 10 days following discharge&#xD;
      from the unit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2012</start_date>
  <completion_date type="Actual">October 5, 2012</completion_date>
  <primary_completion_date type="Actual">October 5, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma pharmacokinetic (PK) parameters of GSK1322322 and radiolabeled compound following single IV or oral solution dose: AUC(0-infinity), AUC(0-t), Cmax, tmax, t1/2 for IV and oral solution regimens and CL and Vss for IV regimen only</measure>
    <time_frame>Day 1 through Day 8 of Period 1 and Period 2 (16 days)</time_frame>
    <description>Plasma PK parameters will be statistically summarized by treatment. Plasma concentration-time data will be analyzed by non-compartmental methods. Following PK parameters will be studied: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)], AUC(0-t), maximum observed concentration (Cmax), time of occurrence of Cmax (tmax), terminal phase half-life (t1/2) for IV and oral solution regimens and systemic clearance (CL) and volume of distribution (Vss) for IV regimen only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent total recovery of radioactivity in urine and feces in each interval and cumulative</measure>
    <time_frame>Day 1 through Day 8 (and additional days, if required) of Period 1 and Period 2 (16 days or more)</time_frame>
    <description>Total recovery of radioactivity in urine and feces (as a percentage of total radioactive dose in each interval and cumulative)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs</measure>
    <time_frame>Duration of the study (56 days)</time_frame>
    <description>To evaluate the safety and tolerability of GSK1322322 after single IV and oral solution doses in healthy subjects safety parameters will be analyzed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Infections, Bacterial</condition>
  <arm_group>
    <arm_group_label>GSK1322322 1000 mg IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On Day 1 of Period 1, after an overnight fast, subjects will receive GSK1322322 1000 mg IV single dose (containing approximately 45.5 microcurie [μCi] radioactive 14C-GSK1322322) for intravenous infusion over 60 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK1322322 1200 mg Oral Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On Day 1 of Period 2, after an overnight fast, subjects will receive GSK1322322 1200 mg oral solution single dose (containing approximately 54.5 μCi radioactive 14C-GSK1322322).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK1322322 1000 mg containing radioactive 14C-GSK1322322</intervention_name>
    <description>GSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base.</description>
    <arm_group_label>GSK1322322 1000 mg IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK1322322 1200 mg containing radioactive 14C-GSK1322322</intervention_name>
    <description>GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.</description>
    <arm_group_label>GSK1322322 1200 mg Oral Solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects between 30 and 55 years of age, with body weight between 60 to&#xD;
             80 kilograms (kg) and a history of regular bowel movements&#xD;
&#xD;
          -  Male subjects with female partners of child-bearing potential must agree to use one of&#xD;
             the contraception methods from first dose of study medication until the final follow&#xD;
             up visit&#xD;
&#xD;
          -  Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin =&lt;1.5x upper limit&#xD;
             of normal&#xD;
&#xD;
          -  QT interval by Bazett's correction formula (QTcB) &lt;450 millisecond (msec); or QTcB&#xD;
             &lt;480 msec in subjects with Bundle Branch Block&#xD;
&#xD;
          -  Available to complete the study and return for follow-up visits if necessary&#xD;
&#xD;
          -  Capable of giving written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that could interfere with the accurate assessment and recovery of&#xD;
             radioactivity [14C]&#xD;
&#xD;
          -  Participation in a clinical trial involving administration of radiolabeled&#xD;
             14C-labelled compound(s) within the last 12 months&#xD;
&#xD;
          -  Any condition which impairs the absorption, distribution, metabolism or excretion of&#xD;
             the investigational product&#xD;
&#xD;
          -  Subjects with a history of cholecystectomy&#xD;
&#xD;
          -  Subject has received a total body radiation dose of greater than 5.0 millisievert&#xD;
             (mSv) or exposure to significant radiation during 1 year before dosing&#xD;
&#xD;
          -  The subject has a positive: drug/alcohol, Hepatitis, HIV screen&#xD;
&#xD;
          -  Abuse of alcohol&#xD;
&#xD;
          -  History of liver disease, or known hepatic or biliary abnormalities&#xD;
&#xD;
          -  The subject has recently received an investigational product&#xD;
&#xD;
          -  Donation of more than 500 mL blood within a 56 day period&#xD;
&#xD;
          -  Unwillingness or inability to follow the procedures outlined in the protocol&#xD;
&#xD;
          -  Use of prescription or non-prescription drugs&#xD;
&#xD;
          -  Subject is mentally or legally incapacitated&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin-induced thrombocytopenia&#xD;
&#xD;
          -  Smoking or history or regular use of tobacco or nicotine-containing products&#xD;
&#xD;
          -  Unable to refrain from consumption of red wine, Seville oranges, grapefruit or&#xD;
             grapefruit juice from 7 days prior to the first dose&#xD;
&#xD;
          -  History of cardiac disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>June 9, 2017</last_update_submitted>
  <last_update_submitted_qc>June 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mass balance</keyword>
  <keyword>radiolabel</keyword>
  <keyword>oral</keyword>
  <keyword>IV</keyword>
  <keyword>GSK1322322</keyword>
  <keyword>healthy volunteer</keyword>
  <keyword>antibiotic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>112167</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>112167</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>112167</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>112167</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>112167</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>112167</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>112167</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT01663389
org study id: 112167
nct id: NCT01663389
lead sponsor: 
has dmc: No
This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study.
      This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion,
      and pharmacokinetics of GSK1322322 in 6 healthy adult male subjects through the sampling of
      blood, urine, and feces.

      Each subject will participate in the study for approximately 7 to 8 weeks i.e., 30 day
      screening period, two dosing periods (approximately 8 days each) and a follow up visit.

      The subjects will be admitted to the clinical unit on Day 1 of the first treatment period and
      remain in the unit for up to approximately 16 days through the end of the second treatment
      period.

      On Day 1 of Period 1, each subject will receive 14C radiolabeled GSK1322322 as a single
      therapeutic intravenous (IV) dose (1000 milligrams [mg]). When the total radioactivity is <1%
      of the administered dose in all subjects, Period 2 dosing will begin (approximately 8 days
      after the IV dose). On Day 1 of Period 2, each subject will receive single therapeutic oral
      solution dose (1200 mg). Blood, urine, bile and fecal samples will be collected during both
      the periods. The subject may be discharged from the unit as early as Day 8 of Period 2.
      Subjects will visit the study unit for the follow-up visit 7 to 10 days following discharge
      from the unit.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma pharmacokinetic (PK) parameters of GSK1322322 and radiolabeled compound following single IV or oral solution dose: AUC(0-infinity), AUC(0-t), Cmax, tmax, t1/2 for IV and oral solution regimens and CL and Vss for IV regimen only
time frame: Day 1 through Day 8 of Period 1 and Period 2 (16 days)
description: Plasma PK parameters will be statistically summarized by treatment. Plasma concentration-time data will be analyzed by non-compartmental methods. Following PK parameters will be studied: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)], AUC(0-t), maximum observed concentration (Cmax), time of occurrence of Cmax (tmax), terminal phase half-life (t1/2) for IV and oral solution regimens and systemic clearance (CL) and volume of distribution (Vss) for IV regimen only.
measure: Percent total recovery of radioactivity in urine and feces in each interval and cumulative
time frame: Day 1 through Day 8 (and additional days, if required) of Period 1 and Period 2 (16 days or more)
description: Total recovery of radioactivity in urine and feces (as a percentage of total radioactive dose in each interval and cumulative)
measure: Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs
time frame: Duration of the study (56 days)
description: To evaluate the safety and tolerability of GSK1322322 after single IV and oral solution doses in healthy subjects safety parameters will be analyzed.
arm group label: GSK1322322 1000 mg IV
arm group type: Experimental
description: On Day 1 of Period 1, after an overnight fast, subjects will receive GSK1322322 1000 mg IV single dose (containing approximately 45.5 microcurie [μCi] radioactive 14C-GSK1322322) for intravenous infusion over 60 minutes.
arm group label: GSK1322322 1200 mg Oral Solution
arm group type: Experimental
description: On Day 1 of Period 2, after an overnight fast, subjects will receive GSK1322322 1200 mg oral solution single dose (containing approximately 54.5 μCi radioactive 14C-GSK1322322).
intervention type: Drug
intervention name: GSK1322322 1000 mg containing radioactive 14C-GSK1322322
description: GSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base.
arm group label: GSK1322322 1000 mg IV
intervention type: Drug
intervention name: GSK1322322 1200 mg containing radioactive 14C-GSK1322322
description: GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.
arm group label: GSK1322322 1200 mg Oral Solution
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United States
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Bacterial Infections
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 