<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/NCT01666613</url>
  </required_header>
  <id_info>
    <org_study_id>D1883C00008</org_study_id>
    <secondary_id>EudraCT number 2012-002901-23</secondary_id>
    <nct_id>NCT01666613</nct_id>
  </id_info>
  <brief_title>A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD8683 When Administered in Different Ways</brief_title>
  <official_title>A Phase I, Single-centre, Open-label, Partly Randomised, Cross-over Single Dose Study in Healthy Volunteers to Evaluate the Absolute Pulmonary Bioavailability of AZD8683 When Administered Inhaled Via a New Dry Powder Inhaler and Via Turbuhaler™</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to look at drug levels of AZD8683 in blood when the drug is&#xD;
      administered in different ways - orally, intravenously or inhaled (with two different&#xD;
      devices), to healthy subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase I, Single-centre, Open-label, Partly Randomised, Cross-over Single Dose Study in&#xD;
      Healthy Volunteers to Evaluate the Absolute Pulmonary Bioavailability of AZD8683 when&#xD;
      Administered Inhaled via a New Dry Powder Inhaler and via Turbuhaler™&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">March 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute pulmonary bioavailability of AZD8683 delivered by the new dry powder inhaler in terms of: Fpulmonary</measure>
    <time_frame>Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute pulmonary bioavailability of AZD8683 delivered by the Turbuhaler™ in terms of: Fpulmonary</measure>
    <time_frame>Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of AZD8683 following administration in terms of oral inhalation by Turbuhaler™ and New Dry Powder Inhaler in terms of: Finhalation total, FrelAUC, Frel Cmax and Foral</measure>
    <time_frame>Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72, 96, 120 and 144 hours post dose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of AZD8683 following oral administration in terms of: Fpo</measure>
    <time_frame>Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12 ,24, 36, and 48 hours post dose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of AZD8683 following oral administration and oral inhalation by Turbuhaler™ and New Dry Powder inhaler in terms of : AUC, AUC(0-t), Cmax, tmax, t½λz, MRT and MAT.</measure>
    <time_frame>Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72 96, 120 and 144 hours post dose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of AZD8683 following i.v. administration in terms of: CL, Vz, and Vss</measure>
    <time_frame>Blood samples taken pre-dose and at 5, 15, 20, 25 and 40 minutes and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety profile in terms of adverse events, ECG, heart rate, blood pressure, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis.</measure>
    <time_frame>Screening to 4 weeks after last dose.</time_frame>
    <description>No formal statistical tests will be performed.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZD8683 iv</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZD8683 oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZD8683 inhalation New Dry Powder Inhaler</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZD8683 inhalation Turbuhaler™</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD8683</intervention_name>
    <description>Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD8683</intervention_name>
    <description>Solution to be administered orally Total dose of 950 µg AZD8683</description>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD8683</intervention_name>
    <description>Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683</description>
    <arm_group_label>3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD8683</intervention_name>
    <description>Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683</description>
    <arm_group_label>4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or women of non-childbearing potential aged 18-45 years inclusive with&#xD;
             suitable veins for cannulation or repeated vein puncture&#xD;
&#xD;
          -  Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weight between 50&#xD;
             and 100 kg (inclusive)&#xD;
&#xD;
          -  Be able to inhale from the inhaler devices used in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any clinically significant disease or disorder&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Any clinically relevant abnormal findings in physical examination or laboratory&#xD;
             values.&#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>
  <overall_official>
    <last_name>Carin Jorup, MD</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca R&amp;D, Molndal Sweden</affiliation>
  </overall_official>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>December 18, 2012</last_update_submitted>
  <last_update_submitted_qc>December 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase I, Healthy volunteers, pharmacokinetics</keyword>
  <keyword>Bioavailability</keyword>
  <keyword>AUC</keyword>
  <!-- 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/NCT01666613
org study id: D1883C00008
secondary id: EudraCT number 2012-002901-23
nct id: NCT01666613
lead sponsor: 
The purpose of this study is to look at drug levels of AZD8683 in blood when the drug is
      administered in different ways - orally, intravenously or inhaled (with two different
      devices), to healthy subjects
A Phase I, Single-centre, Open-label, Partly Randomised, Cross-over Single Dose Study in
      Healthy Volunteers to Evaluate the Absolute Pulmonary Bioavailability of AZD8683 when
      Administered Inhaled via a New Dry Powder Inhaler and via Turbuhaler™
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Absolute pulmonary bioavailability of AZD8683 delivered by the new dry powder inhaler in terms of: Fpulmonary
time frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose.
measure: Absolute pulmonary bioavailability of AZD8683 delivered by the Turbuhaler™ in terms of: Fpulmonary
time frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose.
measure: Pharmacokinetics of AZD8683 following administration in terms of oral inhalation by Turbuhaler™ and New Dry Powder Inhaler in terms of: Finhalation total, FrelAUC, Frel Cmax and Foral
time frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72, 96, 120 and 144 hours post dose.
measure: Pharmacokinetics of AZD8683 following oral administration in terms of: Fpo
time frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12 ,24, 36, and 48 hours post dose.
measure: Pharmacokinetics of AZD8683 following oral administration and oral inhalation by Turbuhaler™ and New Dry Powder inhaler in terms of : AUC, AUC(0-t), Cmax, tmax, t½λz, MRT and MAT.
time frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72 96, 120 and 144 hours post dose.
measure: Pharmacokinetics of AZD8683 following i.v. administration in terms of: CL, Vz, and Vss
time frame: Blood samples taken pre-dose and at 5, 15, 20, 25 and 40 minutes and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose.
measure: Safety profile in terms of adverse events, ECG, heart rate, blood pressure, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis.
time frame: Screening to 4 weeks after last dose.
description: No formal statistical tests will be performed.
arm group label: 1
arm group type: Experimental
description: AZD8683 iv
arm group label: 2
arm group type: Experimental
description: AZD8683 oral
arm group label: 3
arm group type: Experimental
description: AZD8683 inhalation New Dry Powder Inhaler
arm group label: 4
arm group type: Experimental
description: AZD8683 inhalation Turbuhaler™
intervention type: Drug
intervention name: AZD8683
description: Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683
arm group label: 1
intervention type: Drug
intervention name: AZD8683
description: Solution to be administered orally Total dose of 950 µg AZD8683
arm group label: 2
intervention type: Drug
intervention name: AZD8683
description: Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683
arm group label: 3
intervention type: Drug
intervention name: AZD8683
description: Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683
arm group label: 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carin Jorup, MD
role: Study Director
affiliation: AstraZeneca R&D, Molndal Sweden
responsible party type: Sponsor