xml: <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/NCT06007534</url>
    </required_header>
    <id_info>
      <org_study_id>APHP221156</org_study_id>
      <nct_id>NCT06007534</nct_id>
    </id_info>
    <brief_title>Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments</brief_title>
    <acronym>DOXY-PK</acronym>
    <official_title>Caractérisation de la pharmacocinétique d'Une Dose Unique de 200 mg de Doxycycline en Prophylaxie Post-exposition (PEP) Des Infections Sexuellement Transmissibles Dans différents Compartiments Biologiques</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</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>
        Post-exposure prophylaxis (PEP) using doxycycline 200 mg within 24 hours of unprotected&#xD;
        sexual intercourse to prevent sexually transmitted infections has demonstrated a reduction in&#xD;
        the incidence of chlamydial and syphilis infections and syphilis infection by 70% and 73% in&#xD;
        men who have sex with men (MSM) undergoing pre-exposure prophylaxis prophylaxis (PrEP) for&#xD;
        HIV. Other studies are underway or in development on doxycycline prophylaxis for bacterial&#xD;
        STIs, which are particularly common in this population. Monitoring adherence to PEP is of&#xD;
        great interest in guaranteeing the effectiveness of this strategy and to be able to assess&#xD;
        the uptake of PEP among PrEP users. Among the many methods for assessing adherence, measuring&#xD;
        drug concentrations is a more accurate measure of adherence than self-reporting.&#xD;
  &#xD;
        The therapeutic monitoring of doxycycline and the assessment of adherence have been described&#xD;
        using plasma and hair samples, allowing estimation of intake over the last 3-4 days and 4&#xD;
        months, respectively. Nevertheless, these biological matrices present several limitations for&#xD;
        application in clinical practice: reflecting the duration of exposure should be more in line&#xD;
        with the frequency of visits (2 months), and the collection of hair samples may be difficult&#xD;
        due to refusal or short hair. On the other hand, interpretation of the hair assay is limited&#xD;
        by the degradation of doxycycline in this matrix, which could lead to underestimation of drug&#xD;
        intake. By Therefore, new biological matrices are needed for more accurate assessment of&#xD;
        doxycycline adherence in post-exposure prevention monitoring.&#xD;
  &#xD;
        The objective is to evaluate the pharmacokinetics of doxycycline in plasma, whole blood,&#xD;
        dried blood spots (DBS), urine and hair after a single dose of doxycycline in men using oral&#xD;
        doxycycline for post-exposure prophylaxis of sexually transmitted infections (syphilis or&#xD;
        Chlamydia trachomatis) and having sex with men.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>N/A</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>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Concentration of doxycycline in urine</measure>
      <time_frame>At Day 90</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in plasma</measure>
      <time_frame>Before the single intake of doxycycline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in plasma</measure>
      <time_frame>2 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in plasma</measure>
      <time_frame>24 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in plasma</measure>
      <time_frame>48 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in plasma</measure>
      <time_frame>7 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in plasma</measure>
      <time_frame>14 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in plasma</measure>
      <time_frame>30 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in plasma</measure>
      <time_frame>60 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in plasma</measure>
      <time_frame>90 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in whole blood</measure>
      <time_frame>Before the single intake of doxycycline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in whole blood</measure>
      <time_frame>2 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in whole blood</measure>
      <time_frame>24 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in whole blood</measure>
      <time_frame>48 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in whole blood</measure>
      <time_frame>7 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in whole blood</measure>
      <time_frame>14 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in whole blood</measure>
      <time_frame>30 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in whole blood</measure>
      <time_frame>60 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in whole blood</measure>
      <time_frame>90 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in Dried Blood Spot (DBS)</measure>
      <time_frame>Before the single intake of doxycycline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in Dried Blood Spot (DBS)</measure>
      <time_frame>2 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in Dried Blood Spot (DBS)</measure>
      <time_frame>24 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in Dried Blood Spot (DBS)</measure>
      <time_frame>48 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in Dried Blood Spot (DBS)</measure>
      <time_frame>7 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in Dried Blood Spot (DBS)</measure>
      <time_frame>14 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in Dried Blood Spot (DBS)</measure>
      <time_frame>30 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in Dried Blood Spot (DBS)</measure>
      <time_frame>60 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in Dried Blood Spot (DBS)</measure>
      <time_frame>90 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in urine</measure>
      <time_frame>Before the single intake of doxycycline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in urine</measure>
      <time_frame>2 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in urine</measure>
      <time_frame>24 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in urine</measure>
      <time_frame>48 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in urine</measure>
      <time_frame>7 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in urine</measure>
      <time_frame>14 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in urine</measure>
      <time_frame>30 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycyline in urine</measure>
      <time_frame>60 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycycline in oropharyngeal secretions</measure>
      <time_frame>Before the single intake of doxycycline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycycline in oropharyngeal secretions</measure>
      <time_frame>2 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycycline in oropharyngeal secretions</measure>
      <time_frame>24 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycycline in oropharyngeal secretions</measure>
      <time_frame>48 hours after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycycline in oropharyngeal secretions</measure>
      <time_frame>7 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycycline in oropharyngeal secretions</measure>
      <time_frame>14 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycycline in oropharyngeal secretions</measure>
      <time_frame>30 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycycline in oropharyngeal secretions</measure>
      <time_frame>60 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of doxycycline in oropharyngeal secretions</measure>
      <time_frame>90 days after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Doxycycline concentration in hair</measure>
      <time_frame>Before the single intake of doxycycline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Doxycycline concentration in hair</measure>
      <time_frame>1 month after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Doxycycline concentration in hair</measure>
      <time_frame>3 months after doxycycline intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of biological matrix(es) associated with a quantifiable doxycycline dosage</measure>
      <time_frame>Up to 15 days</time_frame>
      <description>Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of biological matrix(es) associated with a quantifiable doxycycline dosage</measure>
      <time_frame>Up to 30 days</time_frame>
      <description>Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of biological matrix(es) associated with a quantifiable doxycycline dosage</measure>
      <time_frame>Up to 60 days</time_frame>
      <description>Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of biological matrix(es) associated with a quantifiable doxycycline dosage</measure>
      <time_frame>Up to 90 days</time_frame>
      <description>Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax (maximum concentration) in plasma</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax (maximum concentration) in whole blood</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax (maximum concentration) in Dried Blood Spot (DBS)</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax (maximum concentration) in urine</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax (maximum concentration) in hair</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC (area under the curve) in plasma</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC (area under the curve) in whole blood</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC (area under the curve) in Dried Blood Spot (DBS)</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC (area under the curve) in urine</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC (area under the curve) in hair</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination clearance in plasma</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination clearance in whole blood</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination clearance in Dried Blood Spot (DBS)</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination clearance in urine</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination clearance in hair</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-life in plasma</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-life in whole blood</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-life in Dried Blood Spot (DBS)</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-life in urine</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-life in hair</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean residence time in plasma</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean residence time in whole blood</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean residence time in Dried Blood Spot (DBS)</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean residence time in urine</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean residence time in hair</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of distribution in plasma</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of distribution in whole blood</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of distribution in Dried Blood Spot (DBS)</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of distribution in urine</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of distribution in hair</measure>
      <time_frame>Until day 90</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Post-exposure Prophylaxis</condition>
    <condition>Sexually Transmitted Diseases</condition>
    <condition>Doxycycline</condition>
    <arm_group>
      <arm_group_label>Adult male patient</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Men having Sex with Men on PrEP (pre-Exposition Prophylaxy) regularly taking doxycycline for Sexually Transmitted Infection (STI) prevention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Samples</intervention_name>
      <description>Blood samples, urine samples and oropharyngeal swabs before taking 200mg of doxycycline and then 2h, 24h, 48h, 7 days, 14 days, 60 days and 90 days after the single dose of doxycycline Hair samples: at the time of doxycycline administration, 1 month and 3 months after the single dose of doxycycline</description>
      <arm_group_label>Adult male patient</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult male patient&#xD;
  &#xD;
            -  Men who have Sex with Men (MSM) on PrEP regularly taking doxycycline for Sexually&#xD;
               Transmitted Infections (STI) prevention&#xD;
  &#xD;
            -  Has not taken doxycycline for at least 3 months&#xD;
  &#xD;
            -  No symptoms of bacterial STI infection (chlamydia, gonorrhea, Mycoplasma genitalium or&#xD;
               syphilis).&#xD;
  &#xD;
            -  Documented history of bacterial STI infection within the past 12 months&#xD;
  &#xD;
            -  Having had a risky intercourse within 24 hours and at the latest within 72 hours and&#xD;
               for which a prescription of doxycycline in a single dose of 200 mg has been made&#xD;
               within the framework of his usual follow-up.&#xD;
  &#xD;
            -  Free, informed, written consent, signed by the person and the investigator at the&#xD;
               latest on the day of inclusion and before any examination carried out within the&#xD;
               framework of the study (article L1122-1-1 of the Public Health Code).&#xD;
  &#xD;
            -  Person affiliated or benefiting from a social security system (article L1121-11 of the&#xD;
               Public Health Code)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Systemic treatment with retinoids (Acnetrait®, Procuta®, Curacné®, Contracné®, ....).&#xD;
  &#xD;
            -  Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital,&#xD;
               phenytoin, etc.).&#xD;
  &#xD;
            -  Known allergy to antibiotics of the tetracycline family.&#xD;
  &#xD;
            -  Known allergy to one of the components of doxycycline tablets.&#xD;
  &#xD;
            -  Documented esophageal injury&#xD;
  &#xD;
            -  Ongoing treatment with doxycycline at the time of inclusion.&#xD;
  &#xD;
            -  Person participating in another research study with an exclusion period still in&#xD;
               progress at inclusion.&#xD;
  &#xD;
            -  Persons under guardianship, conservatorship, or deprived of liberty by judicial or&#xD;
               administrative decision.&#xD;
  &#xD;
            -  Patients on State Medical Aid&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lauriane GOLDWIRT, Dr</last_name>
      <phone>+33 1 42 49 43 25</phone>
      <email>lauriane.goldwirt@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jérôme Lambert, Dr</last_name>
      <phone>+33142499742</phone>
      <email>jerome.lambert@u-paris.fr</email>
    </overall_contact_backup>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sexually Transmitted Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007534
  org study id: APHP221156
  nct id: NCT06007534
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Post-exposure prophylaxis (PEP) using doxycycline 200 mg within 24 hours of unprotected
        sexual intercourse to prevent sexually transmitted infections has demonstrated a reduction in
        the incidence of chlamydial and syphilis infections and syphilis infection by 70% and 73% in
        men who have sex with men (MSM) undergoing pre-exposure prophylaxis prophylaxis (PrEP) for
        HIV. Other studies are underway or in development on doxycycline prophylaxis for bacterial
        STIs, which are particularly common in this population. Monitoring adherence to PEP is of
        great interest in guaranteeing the effectiveness of this strategy and to be able to assess
        the uptake of PEP among PrEP users. Among the many methods for assessing adherence, measuring
        drug concentrations is a more accurate measure of adherence than self-reporting.
  
        The therapeutic monitoring of doxycycline and the assessment of adherence have been described
        using plasma and hair samples, allowing estimation of intake over the last 3-4 days and 4
        months, respectively. Nevertheless, these biological matrices present several limitations for
        application in clinical practice: reflecting the duration of exposure should be more in line
        with the frequency of visits (2 months), and the collection of hair samples may be difficult
        due to refusal or short hair. On the other hand, interpretation of the hair assay is limited
        by the degradation of doxycycline in this matrix, which could lead to underestimation of drug
        intake. By Therefore, new biological matrices are needed for more accurate assessment of
        doxycycline adherence in post-exposure prevention monitoring.
  
        The objective is to evaluate the pharmacokinetics of doxycycline in plasma, whole blood,
        dried blood spots (DBS), urine and hair after a single dose of doxycycline in men using oral
        doxycycline for post-exposure prophylaxis of sexually transmitted infections (syphilis or
        Chlamydia trachomatis) and having sex with men.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Concentration of doxycycline in urine
  time frame: At Day 90
  measure: Concentration of doxycyline in plasma
  time frame: Before the single intake of doxycycline
  measure: Concentration of doxycyline in plasma
  time frame: 2 hours after doxycycline intake
  measure: Concentration of doxycyline in plasma
  time frame: 24 hours after doxycycline intake
  measure: Concentration of doxycyline in plasma
  time frame: 48 hours after doxycycline intake
  measure: Concentration of doxycyline in plasma
  time frame: 7 days after doxycycline intake
  measure: Concentration of doxycyline in plasma
  time frame: 14 days after doxycycline intake
  measure: Concentration of doxycyline in plasma
  time frame: 30 days after doxycycline intake
  measure: Concentration of doxycyline in plasma
  time frame: 60 days after doxycycline intake
  measure: Concentration of doxycyline in plasma
  time frame: 90 days after doxycycline intake
  measure: Concentration of doxycyline in whole blood
  time frame: Before the single intake of doxycycline
  measure: Concentration of doxycyline in whole blood
  time frame: 2 hours after doxycycline intake
  measure: Concentration of doxycyline in whole blood
  time frame: 24 hours after doxycycline intake
  measure: Concentration of doxycyline in whole blood
  time frame: 48 hours after doxycycline intake
  measure: Concentration of doxycyline in whole blood
  time frame: 7 days after doxycycline intake
  measure: Concentration of doxycyline in whole blood
  time frame: 14 days after doxycycline intake
  measure: Concentration of doxycyline in whole blood
  time frame: 30 days after doxycycline intake
  measure: Concentration of doxycyline in whole blood
  time frame: 60 days after doxycycline intake
  measure: Concentration of doxycyline in whole blood
  time frame: 90 days after doxycycline intake
  measure: Concentration of doxycyline in Dried Blood Spot (DBS)
  time frame: Before the single intake of doxycycline
  measure: Concentration of doxycyline in Dried Blood Spot (DBS)
  time frame: 2 hours after doxycycline intake
  measure: Concentration of doxycyline in Dried Blood Spot (DBS)
  time frame: 24 hours after doxycycline intake
  measure: Concentration of doxycyline in Dried Blood Spot (DBS)
  time frame: 48 hours after doxycycline intake
  measure: Concentration of doxycyline in Dried Blood Spot (DBS)
  time frame: 7 days after doxycycline intake
  measure: Concentration of doxycyline in Dried Blood Spot (DBS)
  time frame: 14 days after doxycycline intake
  measure: Concentration of doxycyline in Dried Blood Spot (DBS)
  time frame: 30 days after doxycycline intake
  measure: Concentration of doxycyline in Dried Blood Spot (DBS)
  time frame: 60 days after doxycycline intake
  measure: Concentration of doxycyline in Dried Blood Spot (DBS)
  time frame: 90 days after doxycycline intake
  measure: Concentration of doxycyline in urine
  time frame: Before the single intake of doxycycline
  measure: Concentration of doxycyline in urine
  time frame: 2 hours after doxycycline intake
  measure: Concentration of doxycyline in urine
  time frame: 24 hours after doxycycline intake
  measure: Concentration of doxycyline in urine
  time frame: 48 hours after doxycycline intake
  measure: Concentration of doxycyline in urine
  time frame: 7 days after doxycycline intake
  measure: Concentration of doxycyline in urine
  time frame: 14 days after doxycycline intake
  measure: Concentration of doxycyline in urine
  time frame: 30 days after doxycycline intake
  measure: Concentration of doxycyline in urine
  time frame: 60 days after doxycycline intake
  measure: Concentration of doxycycline in oropharyngeal secretions
  time frame: Before the single intake of doxycycline
  measure: Concentration of doxycycline in oropharyngeal secretions
  time frame: 2 hours after doxycycline intake
  measure: Concentration of doxycycline in oropharyngeal secretions
  time frame: 24 hours after doxycycline intake
  measure: Concentration of doxycycline in oropharyngeal secretions
  time frame: 48 hours after doxycycline intake
  measure: Concentration of doxycycline in oropharyngeal secretions
  time frame: 7 days after doxycycline intake
  measure: Concentration of doxycycline in oropharyngeal secretions
  time frame: 14 days after doxycycline intake
  measure: Concentration of doxycycline in oropharyngeal secretions
  time frame: 30 days after doxycycline intake
  measure: Concentration of doxycycline in oropharyngeal secretions
  time frame: 60 days after doxycycline intake
  measure: Concentration of doxycycline in oropharyngeal secretions
  time frame: 90 days after doxycycline intake
  measure: Doxycycline concentration in hair
  time frame: Before the single intake of doxycycline
  measure: Doxycycline concentration in hair
  time frame: 1 month after doxycycline intake
  measure: Doxycycline concentration in hair
  time frame: 3 months after doxycycline intake
  measure: Number of biological matrix(es) associated with a quantifiable doxycycline dosage
  time frame: Up to 15 days
  description: Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.
  measure: Number of biological matrix(es) associated with a quantifiable doxycycline dosage
  time frame: Up to 30 days
  description: Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.
  measure: Number of biological matrix(es) associated with a quantifiable doxycycline dosage
  time frame: Up to 60 days
  description: Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.
  measure: Number of biological matrix(es) associated with a quantifiable doxycycline dosage
  time frame: Up to 90 days
  description: Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.
  measure: Cmax (maximum concentration) in plasma
  time frame: Until day 90
  measure: Cmax (maximum concentration) in whole blood
  time frame: Until day 90
  measure: Cmax (maximum concentration) in Dried Blood Spot (DBS)
  time frame: Until day 90
  measure: Cmax (maximum concentration) in urine
  time frame: Until day 90
  measure: Cmax (maximum concentration) in hair
  time frame: Until day 90
  measure: AUC (area under the curve) in plasma
  time frame: Until day 90
  measure: AUC (area under the curve) in whole blood
  time frame: Until day 90
  measure: AUC (area under the curve) in Dried Blood Spot (DBS)
  time frame: Until day 90
  measure: AUC (area under the curve) in urine
  time frame: Until day 90
  measure: AUC (area under the curve) in hair
  time frame: Until day 90
  measure: Elimination clearance in plasma
  time frame: Until day 90
  measure: Elimination clearance in whole blood
  time frame: Until day 90
  measure: Elimination clearance in Dried Blood Spot (DBS)
  time frame: Until day 90
  measure: Elimination clearance in urine
  time frame: Until day 90
  measure: Elimination clearance in hair
  time frame: Until day 90
  measure: Half-life in plasma
  time frame: Until day 90
  measure: Half-life in whole blood
  time frame: Until day 90
  measure: Half-life in Dried Blood Spot (DBS)
  time frame: Until day 90
  measure: Half-life in urine
  time frame: Until day 90
  measure: Half-life in hair
  time frame: Until day 90
  measure: Mean residence time in plasma
  time frame: Until day 90
  measure: Mean residence time in whole blood
  time frame: Until day 90
  measure: Mean residence time in Dried Blood Spot (DBS)
  time frame: Until day 90
  measure: Mean residence time in urine
  time frame: Until day 90
  measure: Mean residence time in hair
  time frame: Until day 90
  measure: Volume of distribution in plasma
  time frame: Until day 90
  measure: Volume of distribution in whole blood
  time frame: Until day 90
  measure: Volume of distribution in Dried Blood Spot (DBS)
  time frame: Until day 90
  measure: Volume of distribution in urine
  time frame: Until day 90
  measure: Volume of distribution in hair
  time frame: Until day 90
  arm group label: Adult male patient
  arm group type: Other
  description: Men having Sex with Men on PrEP (pre-Exposition Prophylaxy) regularly taking doxycycline for Sexually Transmitted Infection (STI) prevention
  intervention type: Other
  intervention name: Samples
  description: Blood samples, urine samples and oropharyngeal swabs before taking 200mg of doxycycline and then 2h, 24h, 48h, 7 days, 14 days, 60 days and 90 days after the single dose of doxycycline Hair samples: at the time of doxycycline administration, 1 month and 3 months after the single dose of doxycycline
  arm group label: Adult male patient
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lauriane GOLDWIRT, Dr
  phone: +33 1 42 49 43 25
  email: lauriane.goldwirt@aphp.fr
  last name: Jérôme Lambert, Dr
  phone: +33142499742
  email: jerome.lambert@u-paris.fr
  responsible party type: Sponsor
  mesh term: Sexually Transmitted Diseases
  sharing ipd: Undecided