<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/NCT03243760</url>
  </required_header>
  <id_info>
    <org_study_id>202031</org_study_id>
    <secondary_id>2015-003960-35</secondary_id>
    <nct_id>NCT03243760</nct_id>
  </id_info>
  <brief_title>Dose Escalating Study of CCI15106 Inhalation Capsules in Healthy Subjects and Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients</brief_title>
  <official_title>A Double-blind (Sponsor Unblind), Randomized, Placebo-controlled, Single and Repeat Escalating Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of CCI15106 Capsules for Inhalation in Healthy Subjects and Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD)</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 study will be the first administration of CCI15106 capsules for inhalation to humans.&#xD;
      The primary objective of the study is to investigate the safety and tolerability of single&#xD;
      and repeat escalating doses of CCI15106 in healthy subjects and patients with moderate&#xD;
      chronic obstructive pulmonary disease (COPD). The intention of this study is to provide&#xD;
      sufficient confidence in the safety of the molecule delivered by inhalation to inform&#xD;
      progression to further repeat dose and proof of concept studies.&#xD;
&#xD;
      This will be a three-part study. Part 1 will investigate single ascending doses and Part 2&#xD;
      repeat ascending doses in healthy subjects. In Part 3, a single dose will be administered to&#xD;
      patients with moderate COPD.&#xD;
&#xD;
      There will be screening period of up to 30 days. The treatment period will be 3 days for&#xD;
      Parts 1 and 3 and 16 days for Part 2. Follow-up will be performed within 30 days after the&#xD;
      last dose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The trial is terminated before investigation of repeat escalating doses as these will be&#xD;
    conducted with the new formulation instead.&#xD;
  </why_stopped>
  <start_date type="Actual">February 10, 2016</start_date>
  <completion_date type="Actual">August 20, 2016</completion_date>
  <primary_completion_date type="Actual">July 20, 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1: Number of participants with adverse events (AE)</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of participants with AE</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of participants with AE</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal clinical hematology test findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Hematology tests will be performed as a measure of safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal clinical hematology test findings</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>Hematology tests will be performed as a measure of safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal clinical hematology test findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Hematology tests will be performed as a measure of safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal clinical chemistry test findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Clinical chemistry laboratory tests will be performed as a measure of safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal clinical chemistry test findings</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>Clinical chemistry laboratory tests will be performed as a measure of safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal clinical chemistry test findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Clinical chemistry laboratory tests will be performed as a measure of safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal urine analysis test findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Urine analysis tests will be performed as a measure of safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal urine analysis test findings</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>Urine analysis tests will be performed as a measure of safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal urine analysis test findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Urine analysis tests will be performed as a measure of safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal findings of body temperature</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Body temperature will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal findings of body temperature</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>Body temperature will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal findings of body temperature</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Body temperature will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal blood pressure values</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal blood pressure values</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal blood pressure values</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal pulse rate values</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Pulse rate will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal pulse rate values</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>Pulse rate will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal pulse rate values</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Pulse rate will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal respiratory rate values</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Respiratory rate will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal respiratory rate values</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>Respiratory rate will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal respiratory rate values</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Respiratory rate will be measured in a semi-supine position after 5 minutes of rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal electrocardiogram (ECG) findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal ECG findings</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal ECG findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal Telemetry findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Cardiac telemetry will be performed continuously till 4hour post morning dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal telemetry findings</measure>
    <time_frame>Up to 46 days</time_frame>
    <description>Cardiac telemetry will be performed continuously till 4hour post morning dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal telemetry findings</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Cardiac telemetry will be performed continuously till 4hour post morning dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of subjects with abnormal spirometry findings</measure>
    <time_frame>Up to 4 hour post-dose</time_frame>
    <description>Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of subjects with abnormal spirometry findings</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Number of subjects with abnormal spirometry findings</measure>
    <time_frame>Up to 4 hour post dose</time_frame>
    <description>Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Area under the curve (AUC) from time zero to infinity (AUC[0-inf] following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate AUC(0-inf) of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: AUC[0-inf] following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate AUC(0-inf) of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: AUC from time zero to the time of last quantifiable concentration (AUC[0-last]) following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate AUC(0-last) of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: AUC[0-last] following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate AUC(0-last) of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Maximum plasma concentration (Cmax) following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate Cmax of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Cmax following repeat dose administration of CCI15106</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate Cmax of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Cmax following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate Cmax of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: time of maximum concentration (Tmax) following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate Tmax of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Tmax following repeat dose administration of CCI15106</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate Tmax of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Tmax following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate Tmax of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Elimination half life (T1/2) following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate T1/2 of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: T1/2 following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate T1/2 of drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Clearance (CL/F) following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Clearance will be calculated from concentration-time curve based on each individual subject's profile.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>part 3: CL/F following single dose administration of CCI15106</measure>
    <time_frame>Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up</time_frame>
    <description>Clearance will be calculated from concentration-time curve based on each individual subject's profile.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: AUC from time zero to end of dosing interval (AUC[0-tau]) following repeat dose administration of CCI15106</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up</time_frame>
    <description>Blood samples will be collected at specific time points to evaluate AUC(0-tau) of drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1 Concentrations of CCI15106 in ELF and BAL cell pellet</measure>
    <time_frame>Up to 2 hour post-dose</time_frame>
    <description>BAL samples will be collected for assessing concentrations of CCI15106 in lung epithelial lining fluid (ELF) and bronchoalveolar lavage (BAL) cell pellet in cohort D.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Concentrations of CCI15106 in ELF and BAL cell pellet</measure>
    <time_frame>Up to 13 days</time_frame>
    <description>BAL samples will be collected for assessing concentrations of CCI15106 in lung ELF and BAL cell pellet in cohort I.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Number of medical device incidents</measure>
    <time_frame>Day 1</time_frame>
    <description>Device incident is malfunction or deterioration in performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient/user/other person or to a serious deterioration in their state of health. Device incident assessment will be done at the time of each dosing to investigate the performance of the Modified Air Inlet Rotahaler™ device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Number of medical device incidents</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Device incident is malfunction or deterioration in performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient/user/other person or to a serious deterioration in their state of health. Device incident assessment will be done at the time of each dosing to investigate the performance of the Modified Air Inlet Rotahaler™ device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3: Number of medical device incidents</measure>
    <time_frame>Day 1</time_frame>
    <description>Device incident is malfunction or deterioration in performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient/user/other person or to a serious deterioration in their state of health. Device incident assessment will be done at the time of each dosing to investigate the performance of the Modified Air Inlet Rotahaler™ device.</description>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Cohort A: Single dose CCI15106 7.5 mg /Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive single dose of either 1 capsule CCI15106 7.5 milligram (mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B: Single dose CCI15106 15 mg /Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive single dose of either 15 mg CCI15106 (2 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C: Single dose CCI15106 30 mg /Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D: Single dose CCI15106 30 mg /Placebo-BAL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. BAL procedures will be performed in this cohort additionally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort E: Single dose CCI15106 45 mg /Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive single dose of either 45 mg CCI15106 (6 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort F: Single dose CCI15106 60 mg /Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive single dose of either 60 mg CCI15106 (8 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive repeat dose of either 7.5 mg CCI15106 (1 capsule) or matching placebo twice daily (BID) for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort H: CCI15106 15 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive repeat dose of either 15 mg CCI15106 (2 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive repeat dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. BAL procedures will be performed in this cohort additionally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort J: CCI15106 =&lt;30 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects will receive repeat dose of either =&lt; 30 mg CCI15106 (less than or equal to 4 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. The dose for cohort J is unknown at this time and will depend on results seen in the previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort K: Single dose CCI15106 30 mg /Placebo-COPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COPD patients will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CCI15106 7.5 mg capsule</intervention_name>
    <description>Orange capsule containing a white to off-white powder, 21.4 mg of CCI15106: Trehalose:Trileucine 35/55/10 weight by weight (w/w)</description>
    <arm_group_label>Cohort A: Single dose CCI15106 7.5 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort B: Single dose CCI15106 15 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort C: Single dose CCI15106 30 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort D: Single dose CCI15106 30 mg /Placebo-BAL</arm_group_label>
    <arm_group_label>Cohort E: Single dose CCI15106 45 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort F: Single dose CCI15106 60 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_label>Cohort H: CCI15106 15 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_label>Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL</arm_group_label>
    <arm_group_label>Cohort J: CCI15106 =&lt;30 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_label>Cohort K: Single dose CCI15106 30 mg /Placebo-COPD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Orange capsule containing a white to off-white powder, 21.4 mg of Trehalose:Trileucine 85/15 w/w</description>
    <arm_group_label>Cohort A: Single dose CCI15106 7.5 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort B: Single dose CCI15106 15 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort C: Single dose CCI15106 30 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort D: Single dose CCI15106 30 mg /Placebo-BAL</arm_group_label>
    <arm_group_label>Cohort E: Single dose CCI15106 45 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort F: Single dose CCI15106 60 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_label>Cohort H: CCI15106 15 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_label>Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL</arm_group_label>
    <arm_group_label>Cohort J: CCI15106 =&lt;30 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_label>Cohort K: Single dose CCI15106 30 mg /Placebo-COPD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo-2</intervention_name>
    <description>Orange capsule containing a white to off-white powder, 21.4 mg of lactose. Placebo-2 to be used if unexpected safety signals are observed with the use of matching placebo.</description>
    <arm_group_label>Cohort A: Single dose CCI15106 7.5 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort B: Single dose CCI15106 15 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort C: Single dose CCI15106 30 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort D: Single dose CCI15106 30 mg /Placebo-BAL</arm_group_label>
    <arm_group_label>Cohort E: Single dose CCI15106 45 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort F: Single dose CCI15106 60 mg /Placebo</arm_group_label>
    <arm_group_label>Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_label>Cohort H: CCI15106 15 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_label>Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL</arm_group_label>
    <arm_group_label>Cohort J: CCI15106 =&lt;30 mg /Placebo BID 14 Days</arm_group_label>
    <arm_group_label>Cohort K: Single dose CCI15106 30 mg /Placebo-COPD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Healthy Subjects&#xD;
&#xD;
          -  Between 18 and 65 years of age inclusive, at the time of signing the informed consent.&#xD;
&#xD;
          -  Healthy as determined by the investigator.&#xD;
&#xD;
          -  Body weight &gt;= 50 kilogram (kg) for males and 45 kg for females and body mass index&#xD;
             (BMI) within the range 19 - 31 kg/meter square (m^2) (inclusive)&#xD;
&#xD;
          -  Male or Female: Male subjects with female partners of child bearing potential must&#xD;
             comply with the contraception requirements as specified in protocol. A female subject&#xD;
             is eligible to participate if she is of non-reproductive potential.&#xD;
&#xD;
          -  Capable of giving signed informed consent.&#xD;
&#xD;
        For COPD Patients&#xD;
&#xD;
          -  Between 40 and 75 years of age inclusive, at the time of signing the informed consent.&#xD;
&#xD;
          -  Diagnosed with moderate COPD (GOLD class II) by a qualified physician as defined by&#xD;
             the GOLD guidelines (http://www.goldcopd.org/).&#xD;
&#xD;
          -  The subject has spirometry at screening, showing: a) post-bronchodilator forced&#xD;
             expiratory volume in 1 second (FEV1)&gt;=50% and &lt;80% predicted normal; b)&#xD;
             post-bronchodilator FEV1/ forced vital capacity (FVC)&lt;0.7.&#xD;
&#xD;
          -  Subject is a smoker or an ex-smoker.&#xD;
&#xD;
          -  Body weight &gt;= 45 kg and BMI within the range 17 - 32 kg/m^2 (inclusive).&#xD;
&#xD;
          -  Male or Female: Male subjects with female partners of child bearing potential must&#xD;
             comply with the contraception requirements as specified in protocol. A female subject&#xD;
             is eligible to participate if she is of non-reproductive potential.&#xD;
&#xD;
          -  Capable of giving signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For Healthy Subjects&#xD;
&#xD;
          -  Male partners of women who are pregnant or lactating&#xD;
&#xD;
          -  Alanine transaminase (ALT) and/or bilirubin &gt;1.5xupper limit of normal (ULN) (isolated&#xD;
             bilirubin &gt;1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin&#xD;
             &lt;35%).&#xD;
&#xD;
          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities&#xD;
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).&#xD;
&#xD;
          -  QT interval corrected for heart rate (QTc )&gt; 450 millisecond (msec).&#xD;
&#xD;
          -  Heart rate: &lt;40 and &gt;100 beats per minute (bpm) for males and &lt;50 and &gt;100 bpm for&#xD;
             females, PR Interval: &lt;120 and &gt;220 msec, QRS duration: &lt;70 and &gt;120 msec, QTcF&#xD;
             interval: &gt;450 msec&#xD;
&#xD;
          -  Any clinically significant central nervous system (e.g., seizures), cardiac,&#xD;
             pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such&#xD;
             conditions.&#xD;
&#xD;
          -  Unable to refrain from prescription or non-prescription drugs&#xD;
&#xD;
          -  History of regular alcohol consumption within 3 months of the study&#xD;
&#xD;
          -  Breath test indicative of smoking at day -1&#xD;
&#xD;
          -  History of sensitivity to any of the study medications&#xD;
&#xD;
          -  For cohorts that will undergo BAL, contraindications to bronchoalveolar lavage&#xD;
&#xD;
          -  Documented lactose allergy/intolerance for cohorts with lactose placebo if they are&#xD;
             used in the study.&#xD;
&#xD;
          -  Hemoglobin (Hgb) below the lower level of the normal range with one repeat testing&#xD;
             allowed, or known hemoglobinopathies.&#xD;
&#xD;
          -  Known severe hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic&#xD;
             epidermal necrolysis, and erythema multiforme.&#xD;
&#xD;
          -  Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test&#xD;
             result at screening or within 3 months prior to first dose of study treatment.&#xD;
&#xD;
          -  A positive pre-study drug/alcohol screen.&#xD;
&#xD;
          -  A positive test for human immunodeficiency virus (HIV) antibody.&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500 mL within 3 month period.&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigational&#xD;
             product within the following time period prior to the first dosing day in the current&#xD;
             study: 3 months, 5 half-lives or twice the duration of the biological effect of the&#xD;
             investigational product (whichever is longer).&#xD;
&#xD;
          -  Exposure to more than four new chemical entities within 12 months prior to the first&#xD;
             dosing day.&#xD;
&#xD;
        For COPD Patients&#xD;
&#xD;
          -  Male partners of women who are pregnant or lactating.&#xD;
&#xD;
          -  ALT and/or bilirubin &gt;1.5xULN (isolated bilirubin &gt;1.5xULN is acceptable if bilirubin&#xD;
             is fractionated and direct bilirubin &lt;35%).&#xD;
&#xD;
          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities&#xD;
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).&#xD;
&#xD;
          -  QTc &gt; 450 msec or QTc &gt; 480 msec in subjects with Bundle Branch Block.&#xD;
&#xD;
          -  Heart rate: &lt;40 and &gt;100 bpm for males and &lt;50 and &gt;100 bpm for females, PR Interval:&#xD;
             &lt;120 and &gt;220 msec, QRS duration: &lt;70 and &gt;120 msec, QTcF interval: &gt;450 msec&#xD;
&#xD;
          -  Subject has poorly controlled COPD as defined in protocol&#xD;
&#xD;
          -  History of an upper or lower respiratory tract infection requiring antibiotics in the&#xD;
             4 weeks prior to screening.&#xD;
&#xD;
          -  Subject has a diagnosis of active tuberculosis, lung cancer, clinically overt&#xD;
             bronchiectasis, pulmonary fibrosis, asthma or any other respiratory condition that&#xD;
             might, in the opinion of the Investigator, compromise the safety of the subject or&#xD;
             affect the interpretation of the results.&#xD;
&#xD;
          -  Subjects who have past or current medical conditions or diseases that are not well&#xD;
             controlled.&#xD;
&#xD;
          -  Subjects are not allowed to take oral corticosteroids from 4 weeks prior to screening&#xD;
             and for the duration of the study.&#xD;
&#xD;
          -  Patients taking medications for any chronic conditions have to be on stable doses for&#xD;
             4 weeks prior to screening and until after completion of the treatment period. This&#xD;
             includes COPD maintenance therapies (e.g. inhaled corticosteroids, long-acting&#xD;
             beta-agonists, long-acting muscarinic agonists).&#xD;
&#xD;
          -  Didanosine and azathioprine are not allowed.&#xD;
&#xD;
          -  Use of short-acting inhaled bronchodilators is allowed, but patients must be able to&#xD;
             discontinue their medications twice during the study.&#xD;
&#xD;
          -  Use of long-acting bronchodilators is allowed, but patients must be able to modify the&#xD;
             schedule of their medications twice during the study.&#xD;
&#xD;
          -  Unable to refrain from smoking for 2 hour (h) prior to dosing and until all&#xD;
             assessments are complete for 4 h after dosing and also for 1 h prior to any vital&#xD;
             signs and ECG assessments.&#xD;
&#xD;
          -  History of regular alcohol consumption within 3 months of the study&#xD;
&#xD;
          -  History of sensitivity to any of the study medications.&#xD;
&#xD;
          -  Documented lactose allergy/intolerance&#xD;
&#xD;
          -  Impaired renal function (creatinine clearance &lt; 50 mL/ minute).&#xD;
&#xD;
          -  Known severe hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic&#xD;
             epidermal necrolysis, and erythema multiforme.&#xD;
&#xD;
          -  Hgb below the lower level of the normal range with one repeat testing allowed or known&#xD;
             hemoglobinopathies.&#xD;
&#xD;
          -  Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test&#xD;
             result at screening or within 3 months prior to first dose of study treatment.&#xD;
&#xD;
          -  A positive pre-study drug/alcohol screen.&#xD;
&#xD;
          -  A positive test for HIV antibody.&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500 mL within 3 months.&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigational&#xD;
             product within the following time period prior to the first dosing day in the current&#xD;
             study: 3 months, 5 half-lives or twice the duration of the biological effect of the&#xD;
             investigational product (whichever is longer).&#xD;
&#xD;
          -  Exposure to more than four new chemical entities within 12 months prior to the first&#xD;
             dosing day.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 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>London</city>
        <zip>NW10 7EW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CCI15106</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>BAL</keyword>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com/Posting.aspx?ID=20371</ipd_url>
  </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/NCT03243760
org study id: 202031
secondary id: 2015-003960-35
nct id: NCT03243760
lead sponsor: 
has dmc: No
This study will be the first administration of CCI15106 capsules for inhalation to humans.
      The primary objective of the study is to investigate the safety and tolerability of single
      and repeat escalating doses of CCI15106 in healthy subjects and patients with moderate
      chronic obstructive pulmonary disease (COPD). The intention of this study is to provide
      sufficient confidence in the safety of the molecule delivered by inhalation to inform
      progression to further repeat dose and proof of concept studies.

      This will be a three-part study. Part 1 will investigate single ascending doses and Part 2
      repeat ascending doses in healthy subjects. In Part 3, a single dose will be administered to
      patients with moderate COPD.

      There will be screening period of up to 30 days. The treatment period will be 3 days for
      Parts 1 and 3 and 16 days for Part 2. Follow-up will be performed within 30 days after the
      last dose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Part 1: Number of participants with adverse events (AE)
time frame: Up to 33 days
description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
measure: Part 2: Number of participants with AE
time frame: Up to 46 days
description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
measure: Part 3: Number of participants with AE
time frame: Up to 33 days
description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
measure: Part 1: Number of subjects with abnormal clinical hematology test findings
time frame: Up to 33 days
description: Hematology tests will be performed as a measure of safety
measure: Part 2: Number of subjects with abnormal clinical hematology test findings
time frame: Up to 46 days
description: Hematology tests will be performed as a measure of safety
measure: Part 3: Number of subjects with abnormal clinical hematology test findings
time frame: Up to 33 days
description: Hematology tests will be performed as a measure of safety
measure: Part 1: Number of subjects with abnormal clinical chemistry test findings
time frame: Up to 33 days
description: Clinical chemistry laboratory tests will be performed as a measure of safety
measure: Part 2: Number of subjects with abnormal clinical chemistry test findings
time frame: Up to 46 days
description: Clinical chemistry laboratory tests will be performed as a measure of safety
measure: Part 3: Number of subjects with abnormal clinical chemistry test findings
time frame: Up to 33 days
description: Clinical chemistry laboratory tests will be performed as a measure of safety
measure: Part 1: Number of subjects with abnormal urine analysis test findings
time frame: Up to 33 days
description: Urine analysis tests will be performed as a measure of safety
measure: Part 2: Number of subjects with abnormal urine analysis test findings
time frame: Up to 46 days
description: Urine analysis tests will be performed as a measure of safety
measure: Part 3: Number of subjects with abnormal urine analysis test findings
time frame: Up to 33 days
description: Urine analysis tests will be performed as a measure of safety
measure: Part 1: Number of subjects with abnormal findings of body temperature
time frame: Up to 33 days
description: Body temperature will be measured in a semi-supine position after 5 minutes of rest
measure: Part 2: Number of subjects with abnormal findings of body temperature
time frame: Up to 46 days
description: Body temperature will be measured in a semi-supine position after 5 minutes of rest
measure: Part 3: Number of subjects with abnormal findings of body temperature
time frame: Up to 33 days
description: Body temperature will be measured in a semi-supine position after 5 minutes of rest
measure: Part 1: Number of subjects with abnormal blood pressure values
time frame: Up to 33 days
description: Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest
measure: Part 2: Number of subjects with abnormal blood pressure values
time frame: Up to 46 days
description: Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest
measure: Part 3: Number of subjects with abnormal blood pressure values
time frame: Up to 33 days
description: Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest
measure: Part 1: Number of subjects with abnormal pulse rate values
time frame: Up to 33 days
description: Pulse rate will be measured in a semi-supine position after 5 minutes of rest
measure: Part 2: Number of subjects with abnormal pulse rate values
time frame: Up to 46 days
description: Pulse rate will be measured in a semi-supine position after 5 minutes of rest
measure: Part 3: Number of subjects with abnormal pulse rate values
time frame: Up to 33 days
description: Pulse rate will be measured in a semi-supine position after 5 minutes of rest
measure: Part 1: Number of subjects with abnormal respiratory rate values
time frame: Up to 33 days
description: Respiratory rate will be measured in a semi-supine position after 5 minutes of rest
measure: Part 2: Number of subjects with abnormal respiratory rate values
time frame: Up to 46 days
description: Respiratory rate will be measured in a semi-supine position after 5 minutes of rest
measure: Part 3: Number of subjects with abnormal respiratory rate values
time frame: Up to 33 days
description: Respiratory rate will be measured in a semi-supine position after 5 minutes of rest
measure: Part 1: Number of subjects with abnormal electrocardiogram (ECG) findings
time frame: Up to 33 days
description: 12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.
measure: Part 2: Number of subjects with abnormal ECG findings
time frame: Up to 46 days
description: 12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.
measure: Part 3: Number of subjects with abnormal ECG findings
time frame: Up to 33 days
description: 12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.
measure: Part 1: Number of subjects with abnormal Telemetry findings
time frame: Up to 33 days
description: Cardiac telemetry will be performed continuously till 4hour post morning dose.
measure: Part 2: Number of subjects with abnormal telemetry findings
time frame: Up to 46 days
description: Cardiac telemetry will be performed continuously till 4hour post morning dose.
measure: Part 3: Number of subjects with abnormal telemetry findings
time frame: Up to 33 days
description: Cardiac telemetry will be performed continuously till 4hour post morning dose.
measure: Part 1: Number of subjects with abnormal spirometry findings
time frame: Up to 4 hour post-dose
description: Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.
measure: Part 2: Number of subjects with abnormal spirometry findings
time frame: Up to 14 days
description: Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.
measure: Part 3: Number of subjects with abnormal spirometry findings
time frame: Up to 4 hour post dose
description: Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.
measure: Part 1: Area under the curve (AUC) from time zero to infinity (AUC[0-inf] following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate AUC(0-inf) of drug
measure: Part 3: AUC[0-inf] following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate AUC(0-inf) of drug
measure: Part 1: AUC from time zero to the time of last quantifiable concentration (AUC[0-last]) following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate AUC(0-last) of drug
measure: Part 3: AUC[0-last] following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate AUC(0-last) of drug
measure: Part 1: Maximum plasma concentration (Cmax) following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate Cmax of drug
measure: Part 2: Cmax following repeat dose administration of CCI15106
time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up
description: Blood samples will be collected at specific time points to evaluate Cmax of drug
measure: Part 3: Cmax following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate Cmax of drug
measure: Part 1: time of maximum concentration (Tmax) following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate Tmax of drug
measure: Part 2: Tmax following repeat dose administration of CCI15106
time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up
description: Blood samples will be collected at specific time points to evaluate Tmax of drug
measure: Part 3: Tmax following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate Tmax of drug
measure: Part 1: Elimination half life (T1/2) following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate T1/2 of drug
measure: Part 3: T1/2 following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Blood samples will be collected at specific time points to evaluate T1/2 of drug
measure: Part 1: Clearance (CL/F) following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Clearance will be calculated from concentration-time curve based on each individual subject's profile.
measure: part 3: CL/F following single dose administration of CCI15106
time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
description: Clearance will be calculated from concentration-time curve based on each individual subject's profile.
measure: Part 2: AUC from time zero to end of dosing interval (AUC[0-tau]) following repeat dose administration of CCI15106
time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up
description: Blood samples will be collected at specific time points to evaluate AUC(0-tau) of drug
measure: Part 1 Concentrations of CCI15106 in ELF and BAL cell pellet
time frame: Up to 2 hour post-dose
description: BAL samples will be collected for assessing concentrations of CCI15106 in lung epithelial lining fluid (ELF) and bronchoalveolar lavage (BAL) cell pellet in cohort D.
measure: Part 2: Concentrations of CCI15106 in ELF and BAL cell pellet
time frame: Up to 13 days
description: BAL samples will be collected for assessing concentrations of CCI15106 in lung ELF and BAL cell pellet in cohort I.
measure: Part 1: Number of medical device incidents
time frame: Day 1
description: Device incident is malfunction or deterioration in performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient/user/other person or to a serious deterioration in their state of health. Device incident assessment will be done at the time of each dosing to investigate the performance of the Modified Air Inlet Rotahaler™ device.
measure: Part 2: Number of medical device incidents
time frame: Up to 14 days
description: Device incident is malfunction or deterioration in performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient/user/other person or to a serious deterioration in their state of health. Device incident assessment will be done at the time of each dosing to investigate the performance of the Modified Air Inlet Rotahaler™ device.
measure: Part 3: Number of medical device incidents
time frame: Day 1
description: Device incident is malfunction or deterioration in performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient/user/other person or to a serious deterioration in their state of health. Device incident assessment will be done at the time of each dosing to investigate the performance of the Modified Air Inlet Rotahaler™ device.
arm group label: Cohort A: Single dose CCI15106 7.5 mg /Placebo
arm group type: Experimental
description: Healthy subjects will receive single dose of either 1 capsule CCI15106 7.5 milligram (mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
arm group label: Cohort B: Single dose CCI15106 15 mg /Placebo
arm group type: Experimental
description: Healthy subjects will receive single dose of either 15 mg CCI15106 (2 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
arm group label: Cohort C: Single dose CCI15106 30 mg /Placebo
arm group type: Experimental
description: Healthy subjects will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
arm group label: Cohort D: Single dose CCI15106 30 mg /Placebo-BAL
arm group type: Experimental
description: Healthy subjects will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. BAL procedures will be performed in this cohort additionally.
arm group label: Cohort E: Single dose CCI15106 45 mg /Placebo
arm group type: Experimental
description: Healthy subjects will receive single dose of either 45 mg CCI15106 (6 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
arm group label: Cohort F: Single dose CCI15106 60 mg /Placebo
arm group type: Experimental
description: Healthy subjects will receive single dose of either 60 mg CCI15106 (8 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
arm group label: Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days
arm group type: Experimental
description: Healthy subjects will receive repeat dose of either 7.5 mg CCI15106 (1 capsule) or matching placebo twice daily (BID) for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
arm group label: Cohort H: CCI15106 15 mg /Placebo BID 14 Days
arm group type: Experimental
description: Healthy subjects will receive repeat dose of either 15 mg CCI15106 (2 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
arm group label: Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL
arm group type: Experimental
description: Healthy subjects will receive repeat dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. BAL procedures will be performed in this cohort additionally.
arm group label: Cohort J: CCI15106 =<30 mg /Placebo BID 14 Days
arm group type: Experimental
description: Healthy subjects will receive repeat dose of either =< 30 mg CCI15106 (less than or equal to 4 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. The dose for cohort J is unknown at this time and will depend on results seen in the previous cohorts.
arm group label: Cohort K: Single dose CCI15106 30 mg /Placebo-COPD
arm group type: Experimental
description: COPD patients will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
intervention type: Drug
intervention name: CCI15106 7.5 mg capsule
description: Orange capsule containing a white to off-white powder, 21.4 mg of CCI15106: Trehalose:Trileucine 35/55/10 weight by weight (w/w)
arm group label: Cohort A: Single dose CCI15106 7.5 mg /Placebo
arm group label: Cohort B: Single dose CCI15106 15 mg /Placebo
arm group label: Cohort C: Single dose CCI15106 30 mg /Placebo
arm group label: Cohort D: Single dose CCI15106 30 mg /Placebo-BAL
arm group label: Cohort E: Single dose CCI15106 45 mg /Placebo
arm group label: Cohort F: Single dose CCI15106 60 mg /Placebo
arm group label: Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days
arm group label: Cohort H: CCI15106 15 mg /Placebo BID 14 Days
arm group label: Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL
arm group label: Cohort J: CCI15106 =<30 mg /Placebo BID 14 Days
arm group label: Cohort K: Single dose CCI15106 30 mg /Placebo-COPD
intervention type: Drug
intervention name: Placebo
description: Orange capsule containing a white to off-white powder, 21.4 mg of Trehalose:Trileucine 85/15 w/w
arm group label: Cohort A: Single dose CCI15106 7.5 mg /Placebo
arm group label: Cohort B: Single dose CCI15106 15 mg /Placebo
arm group label: Cohort C: Single dose CCI15106 30 mg /Placebo
arm group label: Cohort D: Single dose CCI15106 30 mg /Placebo-BAL
arm group label: Cohort E: Single dose CCI15106 45 mg /Placebo
arm group label: Cohort F: Single dose CCI15106 60 mg /Placebo
arm group label: Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days
arm group label: Cohort H: CCI15106 15 mg /Placebo BID 14 Days
arm group label: Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL
arm group label: Cohort J: CCI15106 =<30 mg /Placebo BID 14 Days
arm group label: Cohort K: Single dose CCI15106 30 mg /Placebo-COPD
intervention type: Drug
intervention name: Placebo-2
description: Orange capsule containing a white to off-white powder, 21.4 mg of lactose. Placebo-2 to be used if unexpected safety signals are observed with the use of matching placebo.
arm group label: Cohort A: Single dose CCI15106 7.5 mg /Placebo
arm group label: Cohort B: Single dose CCI15106 15 mg /Placebo
arm group label: Cohort C: Single dose CCI15106 30 mg /Placebo
arm group label: Cohort D: Single dose CCI15106 30 mg /Placebo-BAL
arm group label: Cohort E: Single dose CCI15106 45 mg /Placebo
arm group label: Cohort F: Single dose CCI15106 60 mg /Placebo
arm group label: Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days
arm group label: Cohort H: CCI15106 15 mg /Placebo BID 14 Days
arm group label: Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL
arm group label: Cohort J: CCI15106 =<30 mg /Placebo BID 14 Days
arm group label: Cohort K: Single dose CCI15106 30 mg /Placebo-COPD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com/Posting.aspx?ID=20371