<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/NCT02205320</url>
  </required_header>
  <id_info>
    <org_study_id>PG-01-003</org_study_id>
    <nct_id>NCT02205320</nct_id>
  </id_info>
  <brief_title>A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Reddy's Laboratories Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Reddy's Laboratories Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers&#xD;
      with three forms of pegylated granulocyte colony stimulating factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>105 days</time_frame>
    <description>Maximum plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf)</measure>
    <time_frame>105 days</time_frame>
    <description>Area under concentration-time curve extrapolated from time 0 to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-t)</measure>
    <time_frame>105 days</time_frame>
    <description>Area under concentration-time curve from time 0 to the time of the last quantifiable concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emax</measure>
    <time_frame>105 days</time_frame>
    <description>Maximum observed effect</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUEC(0-t)</measure>
    <time_frame>105 days</time_frame>
    <description>Area under the effect time curve from time zero (predose) to last measured time</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">192</enrollment>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>Treatment Sequence I (DRL, A, B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence II (DRL, B, A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form B, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence III (A, DRL, B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, DRL_PG, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence IV (A, B, DRL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, Pegfilgrastim Form B, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence V (B, A, DRL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, Pegfilgrastim Form A, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence VI (B, DRL, A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, DRL_PG, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DRL_PG</intervention_name>
    <arm_group_label>Treatment Sequence I (DRL, A, B)</arm_group_label>
    <arm_group_label>Treatment Sequence II (DRL, B, A)</arm_group_label>
    <arm_group_label>Treatment Sequence III (A, DRL, B)</arm_group_label>
    <arm_group_label>Treatment Sequence IV (A, B, DRL)</arm_group_label>
    <arm_group_label>Treatment Sequence V (B, A, DRL)</arm_group_label>
    <arm_group_label>Treatment Sequence VI (B, DRL, A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pegfilgrastim Form A</intervention_name>
    <arm_group_label>Treatment Sequence I (DRL, A, B)</arm_group_label>
    <arm_group_label>Treatment Sequence II (DRL, B, A)</arm_group_label>
    <arm_group_label>Treatment Sequence III (A, DRL, B)</arm_group_label>
    <arm_group_label>Treatment Sequence IV (A, B, DRL)</arm_group_label>
    <arm_group_label>Treatment Sequence V (B, A, DRL)</arm_group_label>
    <arm_group_label>Treatment Sequence VI (B, DRL, A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pegfilgrastim Form B</intervention_name>
    <arm_group_label>Treatment Sequence I (DRL, A, B)</arm_group_label>
    <arm_group_label>Treatment Sequence II (DRL, B, A)</arm_group_label>
    <arm_group_label>Treatment Sequence III (A, DRL, B)</arm_group_label>
    <arm_group_label>Treatment Sequence IV (A, B, DRL)</arm_group_label>
    <arm_group_label>Treatment Sequence V (B, A, DRL)</arm_group_label>
    <arm_group_label>Treatment Sequence VI (B, DRL, A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and female subjects aged 18 to 55 years&#xD;
&#xD;
          2. A standardized body mass index&#xD;
&#xD;
          3. General good health as determined by the Investigator&#xD;
&#xD;
          4. Normal organ function as per the Investigator's judgement&#xD;
&#xD;
          5. Must be non-smokers, or ex-smokers who have not smoked within the previous 6 months&#xD;
             from the screening visit&#xD;
&#xD;
          6. Female subjects must:&#xD;
&#xD;
               -  Not be lactating; not be pregnant&#xD;
&#xD;
               -  Agree to use an acceptable contraceptive method or be of non-childbearing&#xD;
                  potential&#xD;
&#xD;
          7. Male subjects must refrain from donating sperm or fathering a child during the study&#xD;
             and until 3 months after the last study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim&#xD;
             or any other related component&#xD;
&#xD;
          2. Presence of antibodies to polyethylene glycol at screening&#xD;
&#xD;
          3. Positive result for cotinine (&gt;500 ng/mL) or drugs of abuse at screening or on&#xD;
             admission&#xD;
&#xD;
          4. Prior history of or current alcohol abuse or excessive intake of alcohol as judged by&#xD;
             the Investigator&#xD;
&#xD;
          5. Donation of blood (≥500 mL) or plasma within the previous 3 months&#xD;
&#xD;
          6. History of unexplained syncopal episodes;&#xD;
&#xD;
          7. Any disorder that, in the Investigator's opinion, may interfere with study compliance&#xD;
&#xD;
          8. History of any cancer&#xD;
&#xD;
          9. History of pulmonary infiltrate or pneumonia within the previous 6 months from&#xD;
             screening visit&#xD;
&#xD;
         10. Hereditary fructose and/or sorbitol intolerance&#xD;
&#xD;
         11. Absolute neutrophil count below 1500/mm3 or above 12000/mm3 at screening&#xD;
&#xD;
         12. Positive test for hepatitis B surface antigen, hepatitis C antibody, or human&#xD;
             immunodeficiency virus (HIV) 1 or 2&#xD;
&#xD;
         13. Any abnormality in 12-lead ECG that in the Investigator's opinion is clinically&#xD;
             significant and/or suggestive of underlying cardiac abnormalities&#xD;
&#xD;
         14. A clinical diagnosis of hypertension, significant hypercholesterolemia as judged by&#xD;
             the Investigator, or thyroid abnormalities&#xD;
&#xD;
         15. Family history of acute myeloid leukemia or subjects with splenomegaly at baseline, or&#xD;
             with sickle cell disease&#xD;
&#xD;
         16. Any prescribed or over the counter medications including analgesics, herbal remedies,&#xD;
             vitamin therapy must not be used from 7 days prior to the first administration of&#xD;
             study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>QPS Bio-Kinetic</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65802</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dennis Morrison, DO</last_name>
      <phone>417-831-0456</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pegfilgrastim</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</keyword>
  <keyword>Healthy volunteers</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/NCT02205320
org study id: PG-01-003
nct id: NCT02205320
lead sponsor: 
has dmc: No
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers
      with three forms of pegylated granulocyte colony stimulating factors.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Cmax
time frame: 105 days
description: Maximum plasma concentration
measure: AUC(0-inf)
time frame: 105 days
description: Area under concentration-time curve extrapolated from time 0 to infinity
measure: AUC(0-t)
time frame: 105 days
description: Area under concentration-time curve from time 0 to the time of the last quantifiable concentration
measure: Emax
time frame: 105 days
description: Maximum observed effect
measure: AUEC(0-t)
time frame: 105 days
description: Area under the effect time curve from time zero (predose) to last measured time
arm group label: Treatment Sequence I (DRL, A, B)
arm group type: Experimental
description: Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
arm group label: Treatment Sequence II (DRL, B, A)
arm group type: Experimental
description: Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form B, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
arm group label: Treatment Sequence III (A, DRL, B)
arm group type: Experimental
description: Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, DRL_PG, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
arm group label: Treatment Sequence IV (A, B, DRL)
arm group type: Experimental
description: Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, Pegfilgrastim Form B, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
arm group label: Treatment Sequence V (B, A, DRL)
arm group type: Experimental
description: Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, Pegfilgrastim Form A, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
arm group label: Treatment Sequence VI (B, DRL, A)
arm group type: Experimental
description: Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, DRL_PG, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
intervention type: Biological
intervention name: DRL_PG
arm group label: Treatment Sequence I (DRL, A, B)
arm group label: Treatment Sequence II (DRL, B, A)
arm group label: Treatment Sequence III (A, DRL, B)
arm group label: Treatment Sequence IV (A, B, DRL)
arm group label: Treatment Sequence V (B, A, DRL)
arm group label: Treatment Sequence VI (B, DRL, A)
intervention type: Biological
intervention name: Pegfilgrastim Form A
arm group label: Treatment Sequence I (DRL, A, B)
arm group label: Treatment Sequence II (DRL, B, A)
arm group label: Treatment Sequence III (A, DRL, B)
arm group label: Treatment Sequence IV (A, B, DRL)
arm group label: Treatment Sequence V (B, A, DRL)
arm group label: Treatment Sequence VI (B, DRL, A)
intervention type: Biological
intervention name: Pegfilgrastim Form B
arm group label: Treatment Sequence I (DRL, A, B)
arm group label: Treatment Sequence II (DRL, B, A)
arm group label: Treatment Sequence III (A, DRL, B)
arm group label: Treatment Sequence IV (A, B, DRL)
arm group label: Treatment Sequence V (B, A, DRL)
arm group label: Treatment Sequence VI (B, DRL, A)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor