<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/NCT03777488</url>
  </required_header>
  <id_info>
    <org_study_id>2018/KEP/205</org_study_id>
    <nct_id>NCT03777488</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.</brief_title>
  <acronym>PharmacoTXA</acronym>
  <official_title>Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1 study which aims to determine the pharmacokinetics and local and systemic&#xD;
      tolerance of tranexamic acid in healthy volunteers using a population approach after oral,&#xD;
      intramuscular or intravenous administration. It will also determine the feasibility of&#xD;
      measuring tranexamic acid in spots of dry capillary blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifteen healthy volunteers will receive in random order 1 gram of intravenous and&#xD;
      intramuscular injections and 2 grams of oral tranexamic acid solution. Blood samples will be&#xD;
      taken at:&#xD;
&#xD;
        -  T0+ 5min (only for IV route)&#xD;
&#xD;
        -  T0+30min&#xD;
&#xD;
        -  T0+1h&#xD;
&#xD;
        -  T0+2h&#xD;
&#xD;
        -  T0+3h&#xD;
&#xD;
        -  T0+4h&#xD;
&#xD;
        -  T0+5h&#xD;
&#xD;
        -  T0+6h&#xD;
&#xD;
        -  T0+8h (only for IM and PO routes)&#xD;
&#xD;
        -  T0+24h&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2019</start_date>
  <completion_date type="Actual">October 14, 2020</completion_date>
  <primary_completion_date type="Actual">October 14, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous)</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain during after administration (visual analogue scale) for each administration route</measure>
    <time_frame>8 hours</time_frame>
    <description>(Scale 0 - 9) where 0 = no pain and 9 most severe pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reaction at site of injection for intramuscular and Iintravenous routes</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Correlation between serum and dry blood spot concentrations for each administration route</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy Volunteer Study</condition>
  <arm_group>
    <arm_group_label>Tranexamic acid Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive tranexamic acid in the following order:&#xD;
First Dose: Intravenous Second Dose: Intramuscular Third Dose: Oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tranexamic acid Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive tranexamic acid in the following order:&#xD;
First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tranexamic acid Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive tranexamic acid in the following order:&#xD;
First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tranexamic acid Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive tranexamic acid in the following order:&#xD;
First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tranexamic acid Group 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive tranexamic acid in the following order:&#xD;
First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tranexamic acid Group 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive tranexamic acid in the following order:&#xD;
First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid 1 gram intravenously</intervention_name>
    <description>Intravenous tranexamic acid crossover to oral and intramuscular arms</description>
    <arm_group_label>Tranexamic acid Group 1</arm_group_label>
    <arm_group_label>Tranexamic acid Group 2</arm_group_label>
    <arm_group_label>Tranexamic acid Group 3</arm_group_label>
    <arm_group_label>Tranexamic acid Group 4</arm_group_label>
    <arm_group_label>Tranexamic acid Group 5</arm_group_label>
    <arm_group_label>Tranexamic acid Group 6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid 2 grams oral solution</intervention_name>
    <description>Oral tranexamic acid crossover to intravenous and intramuscular arms</description>
    <arm_group_label>Tranexamic acid Group 1</arm_group_label>
    <arm_group_label>Tranexamic acid Group 2</arm_group_label>
    <arm_group_label>Tranexamic acid Group 3</arm_group_label>
    <arm_group_label>Tranexamic acid Group 4</arm_group_label>
    <arm_group_label>Tranexamic acid Group 5</arm_group_label>
    <arm_group_label>Tranexamic acid Group 6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid 1 gram intramuscular</intervention_name>
    <description>Intramuscular tranexamic acid crossover to oral and intravenous arms</description>
    <arm_group_label>Tranexamic acid Group 1</arm_group_label>
    <arm_group_label>Tranexamic acid Group 2</arm_group_label>
    <arm_group_label>Tranexamic acid Group 3</arm_group_label>
    <arm_group_label>Tranexamic acid Group 4</arm_group_label>
    <arm_group_label>Tranexamic acid Group 5</arm_group_label>
    <arm_group_label>Tranexamic acid Group 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult healthy volunteers both men and non-pregnant women&#xD;
&#xD;
          -  ≥18-≤45-year-old&#xD;
&#xD;
          -  Body mass index between ≥18 and ≤30 kg/m2, and bodyweight between ≥50 and ≤100 kg&#xD;
&#xD;
          -  Coagulation test results of fibrinogen, D-dimers, prothrombin time and a partial&#xD;
             thromboplastin time within normal limits at screening&#xD;
&#xD;
          -  Normal renal function based on medical history and laboratory tests&#xD;
&#xD;
          -  If a woman, must have a negative urine β-human chorionic gonadotropin (βhCG) pregnancy&#xD;
             test at screening and inclusion visits&#xD;
&#xD;
          -  Provision of signed informed consent prior to any study specific procedure&#xD;
&#xD;
          -  People with public healthcare insurance (in France)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous thrombotic event or pre-existing pro-thrombotic disease&#xD;
&#xD;
          -  Any history of seizures&#xD;
&#xD;
          -  Any chronic or active cardiovascular or renal disease&#xD;
&#xD;
          -  Planned general anaesthesia or surgery in the 3 months following inclusion&#xD;
&#xD;
          -  Pregnant and/or breastfeeding&#xD;
&#xD;
          -  Known allergy to the study drugs or any of the excipients of the formulations&#xD;
&#xD;
          -  Use of any prescription or non-prescription medication (other than hormonal&#xD;
             contraception) within 7 days before the first dose of the study drug is scheduled&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Previous participation during the year in clinical studies compensated for an amount&#xD;
             incompatible with participation in this study, verified by recording in the national&#xD;
             register of subjects participating in human research trials&#xD;
&#xD;
          -  Legal criteria:&#xD;
&#xD;
               -  People deprived of liberty by judicial or administrative decision&#xD;
&#xD;
               -  Adult protected by law (France)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haleema Shakur-Still</last_name>
    <role>Study Chair</role>
    <affiliation>LSHTM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ian Roberts</last_name>
    <role>Study Chair</role>
    <affiliation>LSHTM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines</name>
      <address>
        <city>Montigny-Le-Bretonneux</city>
        <zip>78180</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unité de Recherche Clinique Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75743</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>November 17, 2020</last_update_submitted>
  <last_update_submitted_qc>November 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacokinetics, tranexamic acid</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</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/NCT03777488
org study id: 2018/KEP/205
nct id: NCT03777488
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a Phase 1 study which aims to determine the pharmacokinetics and local and systemic
      tolerance of tranexamic acid in healthy volunteers using a population approach after oral,
      intramuscular or intravenous administration. It will also determine the feasibility of
      measuring tranexamic acid in spots of dry capillary blood.
Fifteen healthy volunteers will receive in random order 1 gram of intravenous and
      intramuscular injections and 2 grams of oral tranexamic acid solution. Blood samples will be
      taken at:

        -  T0+ 5min (only for IV route)

        -  T0+30min

        -  T0+1h

        -  T0+2h

        -  T0+3h

        -  T0+4h

        -  T0+5h

        -  T0+6h

        -  T0+8h (only for IM and PO routes)

        -  T0+24h
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous)
time frame: 24 hours
measure: Pain during after administration (visual analogue scale) for each administration route
time frame: 8 hours
description: (Scale 0 - 9) where 0 = no pain and 9 most severe pain
measure: Reaction at site of injection for intramuscular and Iintravenous routes
time frame: 24 hours
measure: • Correlation between serum and dry blood spot concentrations for each administration route
time frame: 24 hours
arm group label: Tranexamic acid Group 1
arm group type: Experimental
description: Participants will receive tranexamic acid in the following order:
First Dose: Intravenous Second Dose: Intramuscular Third Dose: Oral
arm group label: Tranexamic acid Group 2
arm group type: Experimental
description: Participants will receive tranexamic acid in the following order:
First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular
arm group label: Tranexamic acid Group 3
arm group type: Experimental
description: Participants will receive tranexamic acid in the following order:
First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral
arm group label: Tranexamic acid Group 4
arm group type: Experimental
description: Participants will receive tranexamic acid in the following order:
First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous
arm group label: Tranexamic acid Group 5
arm group type: Experimental
description: Participants will receive tranexamic acid in the following order:
First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular
arm group label: Tranexamic acid Group 6
arm group type: Experimental
description: Participants will receive tranexamic acid in the following order:
First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous
intervention type: Drug
intervention name: Tranexamic Acid 1 gram intravenously
description: Intravenous tranexamic acid crossover to oral and intramuscular arms
arm group label: Tranexamic acid Group 1
arm group label: Tranexamic acid Group 2
arm group label: Tranexamic acid Group 3
arm group label: Tranexamic acid Group 4
arm group label: Tranexamic acid Group 5
arm group label: Tranexamic acid Group 6
intervention type: Drug
intervention name: Tranexamic acid 2 grams oral solution
description: Oral tranexamic acid crossover to intravenous and intramuscular arms
arm group label: Tranexamic acid Group 1
arm group label: Tranexamic acid Group 2
arm group label: Tranexamic acid Group 3
arm group label: Tranexamic acid Group 4
arm group label: Tranexamic acid Group 5
arm group label: Tranexamic acid Group 6
intervention type: Drug
intervention name: Tranexamic acid 1 gram intramuscular
description: Intramuscular tranexamic acid crossover to oral and intravenous arms
arm group label: Tranexamic acid Group 1
arm group label: Tranexamic acid Group 2
arm group label: Tranexamic acid Group 3
arm group label: Tranexamic acid Group 4
arm group label: Tranexamic acid Group 5
arm group label: Tranexamic acid Group 6
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Haleema Shakur-Still
role: Study Chair
affiliation: LSHTM
last name: Ian Roberts
role: Study Chair
affiliation: LSHTM
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Tranexamic Acid