<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/NCT02206854</url>
  </required_header>
  <id_info>
    <org_study_id>FLIP0112</org_study_id>
    <secondary_id>2012-001425-27</secondary_id>
    <nct_id>NCT02206854</nct_id>
  </id_info>
  <brief_title>Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects</brief_title>
  <official_title>Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gerd Geisslinger</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fraunhofer Institute for Molecular Biology and Applied Ecology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Goethe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study&#xD;
      R-flurbiprofen, will be available as gelatine capsules.&#xD;
&#xD;
      This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine&#xD;
      capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood&#xD;
      samples at different time points. To assess the safety of the administered capsules adverse&#xD;
      events will be documented.&#xD;
&#xD;
      Analysis of lipid signaling molecules in plasma will be done to assess the role of this&#xD;
      molecules as variable for therapeutic effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the curve (AUC)</measure>
    <time_frame>prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration</time_frame>
    <description>assessment of concentration at baseline (0), 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration of study medication</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum concentration (Tmax; hours)</measure>
    <time_frame>prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration (Cmax).</measure>
    <time_frame>prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal elimination half-life (t1/2)</measure>
    <time_frame>prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of volunteers with serious and Non serious adverse events</measure>
    <time_frame>Up to day 15</time_frame>
    <description>Number and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) will be documented at V1 (predose and after administration) and at V3 (follow-up visit 8 to 15 days after administration of study medication)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of plasma lipid profile</measure>
    <time_frame>prior and 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration</time_frame>
    <description>parallel to pK-Analysis plasma lipid profile will be assessed</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>R-flurbiprofen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 mg R-flurbiprofen in gelatine capsules once</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>R-flurbiprofen</intervention_name>
    <description>200 mg gelatine capsule once orally</description>
    <arm_group_label>R-flurbiprofen</arm_group_label>
    <other_name>Tarenflurbil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects aged 18 to 65 years&#xD;
&#xD;
          -  Body mass index (BMI) between 18.5 und 30 kg/m2&#xD;
&#xD;
          -  Subject is judged to be in good health based on medical history, physical examination,&#xD;
             vital sign measurements, and laboratory safety tests&#xD;
&#xD;
          -  Subject has no evidence of clinically significant abnormality on echocardiogram (ECG)&#xD;
             performed at screening visit and/or prior to administration of the study drug&#xD;
&#xD;
          -  Non-Smoker&#xD;
&#xD;
          -  Subjects providing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known hypersensitivity to study medication&#xD;
&#xD;
          -  Subjects who have experienced asthma, urticaria, or allergic-type reactions after&#xD;
             taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)&#xD;
&#xD;
          -  Subjects with a history of peptic ulcer disease and/or gastrointestinal bleeding&#xD;
&#xD;
          -  Pregnant women (pregnancy rapid assay required for women with childbearing potential),&#xD;
             women currently breast-feeding, or with the intention to breast-feed&#xD;
&#xD;
          -  History or evidence of active malignancy within the 24 months prior to entry.&#xD;
&#xD;
          -  Subject has a history of fainting during blood draws.&#xD;
&#xD;
          -  Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 ml)&#xD;
             in the last 4 weeks&#xD;
&#xD;
          -  Subject is currently a regular user (including &quot;recreational use) of illicit drugs or&#xD;
             has a history of drug (including alcohol) abuse within approximately 2 years.&#xD;
&#xD;
          -  Active or history of drug abuse,&#xD;
&#xD;
          -  Chronic or acute renal, hepatic or metabolic disorder&#xD;
&#xD;
          -  Participation in a clinical study within 30 days prior to screening&#xD;
&#xD;
          -  Subjects with immunodeficiencies such as established acquired immunodeficiency&#xD;
             syndrome.&#xD;
&#xD;
          -  Subject is unable to refrain from or anticipates the use of any medication, (including&#xD;
             prescription and non-prescription drugs or herbal remedies (such as St. John's Wort)&#xD;
             beginning approximately 2 weeks (or 5 half-lives) prior to administration of the&#xD;
             initial dose of study drug until the follow-up visit.&#xD;
&#xD;
          -  Subject has a history of any illness that, in the opinion of the study investigator,&#xD;
             might confound the results of the study or poses an additional risk to the subject by&#xD;
             their participation in the study.&#xD;
&#xD;
          -  There is any concern of the investigator regarding the safe participation of the&#xD;
             subject in the study or for any other reason, the investigator considers the subject&#xD;
             inappropriate for participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerd Geisslinger, Prof MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Goethe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johann Wolfgang Goethe University Hospital</name>
      <address>
        <city>Frankfurt</city>
        <zip>60528</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>September 10, 2015</last_update_submitted>
  <last_update_submitted_qc>September 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Goethe University</investigator_affiliation>
    <investigator_full_name>Gerd Geisslinger</investigator_full_name>
    <investigator_title>Professor Dr. Dr. Gerd Geisslinger</investigator_title>
  </responsible_party>
  <keyword>Pharmakokinetic</keyword>
  <keyword>capsules</keyword>
  <keyword>R-Flurbiprofen</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flurbiprofen</mesh_term>
    <mesh_term>Tarenflurbil</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02206854
org study id: FLIP0112
secondary id: 2012-001425-27
nct id: NCT02206854
lead sponsor: 
collaborator: 
has dmc: No
For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study
      R-flurbiprofen, will be available as gelatine capsules.

      This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine
      capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood
      samples at different time points. To assess the safety of the administered capsules adverse
      events will be documented.

      Analysis of lipid signaling molecules in plasma will be done to assess the role of this
      molecules as variable for therapeutic effects.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Area under the curve (AUC)
time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
description: assessment of concentration at baseline (0), 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration of study medication
measure: Time to maximum concentration (Tmax; hours)
time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
measure: Maximum concentration (Cmax).
time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
measure: Terminal elimination half-life (t1/2)
time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
measure: Number of volunteers with serious and Non serious adverse events
time frame: Up to day 15
description: Number and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) will be documented at V1 (predose and after administration) and at V3 (follow-up visit 8 to 15 days after administration of study medication)
measure: Analysis of plasma lipid profile
time frame: prior and 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
description: parallel to pK-Analysis plasma lipid profile will be assessed
arm group label: R-flurbiprofen
arm group type: Experimental
description: 200 mg R-flurbiprofen in gelatine capsules once
intervention type: Drug
intervention name: R-flurbiprofen
description: 200 mg gelatine capsule once orally
arm group label: R-flurbiprofen
other name: Tarenflurbil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gerd Geisslinger, Prof MD
role: Principal Investigator
affiliation: Goethe University
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Goethe University
investigator full name: Gerd Geisslinger
investigator title: Professor Dr. Dr. Gerd Geisslinger
mesh term: Flurbiprofen
mesh term: Tarenflurbil