<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/NCT02249117</url>
  </required_header>
  <id_info>
    <org_study_id>1181.2</org_study_id>
    <nct_id>NCT02249117</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Pharmacodynamics of BIWH 3 in Healthy Duffy Positive vs. Duffy Negative Male Volunteers</brief_title>
  <official_title>Pharmacokinetics and Pharmacodynamics of BIWH 3: a Randomised, Placebo-controlled, Double Blind Dose Escalation Study (0.02, 0.06, 0.2, 0.6, and 2.0 μg/kg Intravenous Over One Hour) in Healthy Duffy Positive vs. Duffy Negative Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of&#xD;
      recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male&#xD;
      volunteers: plasma levels of monocyte chemotactic protein-1 (MCP-1) and markers of leukocyte,&#xD;
      coagulation, platelet and endothelial activation will be quantified; To examine the safety of&#xD;
      BIWH 3 in this setting&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2003</start_date>
  <primary_completion_date type="Actual">August 2003</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve up to the last quantifiable plasma concentration (AUC0-tz)</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>maximum BIWH 3 plasma concentration (Cmax)</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Monocyte activation</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
    <description>Quantification of leukocyte surface markers by flow cytometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet cell activation</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
    <description>Quantification of soluble P-selectin by enzyme immunoassay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial cell activation</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
    <description>Quantification of soluble E-selectin by enzyme immunoassay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory response</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
    <description>Quantification of mRNA expression of IL-1 by reverse transcriptase-polymerase chain reaction (RT-PCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activation of coagulation</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
    <description>Prothrombin fragment levels via an enzyme-immunoassay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in vital signs</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
    <description>blood pressure, pulse rate, body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in ECG</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 14 days after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIWH 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single escalating dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIWH 3</intervention_name>
    <arm_group_label>BIWH 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects as determined by results of screening&#xD;
&#xD;
          -  Erythrocyte Fy positive and negative individuals because expression of the Duffy (Fy)&#xD;
             receptor may influence MCP-1 plasma levels in humans&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 50 years&#xD;
&#xD;
          -  Body mass index: ≥18 kg/m2 and &lt; 30 kg/m2&#xD;
&#xD;
          -  Normal findings in medical history and physical examination unless the investigator&#xD;
             considers an abnormality to be clinically irrelevant&#xD;
&#xD;
          -  Normal laboratory variables unless the investigator considers an abnormality to be&#xD;
             clinically irrelevant&#xD;
&#xD;
          -  Normal pharmacodynamic variables as determined at baseline visit&#xD;
&#xD;
          -  Normal response to glucose tolerance test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding in the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Current or history of: gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunologic, autoimmune, hormonal disorders, diseases of the central&#xD;
             nervous system (such as epilepsy), psychiatric disorders or cancer&#xD;
&#xD;
          -  Symptoms of a clinically relevant illness in the 3 weeks prior to planned&#xD;
             administration of study drug&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells and blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy / hypersensitivity (including drug allergy) which is deemed&#xD;
             relevant to the trial as judged by the investigator&#xD;
&#xD;
          -  Any Electrocardiogram (ECG) value outside the reference range of clinical relevance&#xD;
             including, but not limited to QRS interval &gt; 110 ms or QTcB &gt; 450 ms&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within 1 month prior to planned&#xD;
             administration of study drug&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within 10 days prior&#xD;
             to planned administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 2 months prior to&#xD;
             planned administration or during trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from&#xD;
             smoking on study days&#xD;
&#xD;
          -  Current or history of drug, alcohol, tobacco or caffeine abuse&#xD;
&#xD;
          -  Blood donation within 1 month prior to planned administration or during the trial&#xD;
&#xD;
          -  Excessive physical activities within 5 days prior to planned administration of study&#xD;
             drug or during the trial&#xD;
&#xD;
          -  Seropositivity for hepatitis B antigen (HBs-Ag), hepatitis C (HCV), HIV 1, or HIV 2&#xD;
             antibodies&#xD;
&#xD;
          -  Weight over 95 kg&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02249117
org study id: 1181.2
nct id: NCT02249117
lead sponsor: 
Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of
      recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male
      volunteers: plasma levels of monocyte chemotactic protein-1 (MCP-1) and markers of leukocyte,
      coagulation, platelet and endothelial activation will be quantified; To examine the safety of
      BIWH 3 in this setting
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
time frame: up to 14 days after drug administration
measure: Area under the plasma concentration-time curve up to the last quantifiable plasma concentration (AUC0-tz)
time frame: up to 14 days after drug administration
measure: maximum BIWH 3 plasma concentration (Cmax)
time frame: up to 14 days after drug administration
measure: Monocyte activation
time frame: up to 14 days after drug administration
description: Quantification of leukocyte surface markers by flow cytometry
measure: Platelet cell activation
time frame: up to 14 days after drug administration
description: Quantification of soluble P-selectin by enzyme immunoassay
measure: Endothelial cell activation
time frame: up to 14 days after drug administration
description: Quantification of soluble E-selectin by enzyme immunoassay
measure: Inflammatory response
time frame: up to 14 days after drug administration
description: Quantification of mRNA expression of IL-1 by reverse transcriptase-polymerase chain reaction (RT-PCR)
measure: Activation of coagulation
time frame: up to 14 days after drug administration
description: Prothrombin fragment levels via an enzyme-immunoassay
measure: Number of subjects with adverse events
time frame: up to 14 days after drug administration
measure: Number of subjects with clinically significant findings in vital signs
time frame: up to 14 days after drug administration
description: blood pressure, pulse rate, body temperature
measure: Number of subjects with clinically significant findings in ECG
time frame: up to 14 days after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 14 days after drug administration
arm group label: BIWH 3
arm group type: Experimental
description: single escalating dose
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIWH 3
arm group label: BIWH 3
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor