<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/NCT04420611</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00125</org_study_id>
    <nct_id>NCT04420611</nct_id>
  </id_info>
  <brief_title>Use of Endogenous Melatonin and 6-hydroxymelatonin as Biomarkers for CYP1A2</brief_title>
  <acronym>MelaCYP</acronym>
  <official_title>Use of Endogenous Melatonin and 6-hydroxymelatonin as Biomarkers for CYP1A2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Youssef Daali</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An observational study comprising 4 sessions will be conducted in 12 healthy volunteers.&#xD;
      During each study session (sessions 1 to 4), a 12-hour urine collection during the night&#xD;
      (21h-9h) will be carried out by each participant. The first urine in the morning will be&#xD;
      collected separately to be analysed independently of the 12-hour collection. 24 hours before&#xD;
      the start of the night urine collection, volunteers will be asked to refrain from consuming&#xD;
      alcohol and caffeinated drinks/foods, with the exception of session 3. Conversely, in session&#xD;
      3, subjects will be asked to drink or eat caffeinated food/drinks 24 hours prior to&#xD;
      night-time urine collection (at least one cup of coffee or a can of Coca-Cola®).&#xD;
&#xD;
      After each 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of&#xD;
      coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the&#xD;
      fingertips 2 hours after the coffee or Coca-Cola®.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validation LC-MS/MS analytical method</measure>
    <time_frame>1 month</time_frame>
    <description>Validation of the LC-MS/MS analytical method for simultaneous quantification of endogenous melatonin and 6-hydroxymelatonin in urine samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra- and inter-variability</measure>
    <time_frame>3 days (day 1, day 4 and day 30)</time_frame>
    <description>Assess intra- and inter-variability of the urinary metabolic ratio (UMR) 6-hydroxymelatonin/melatonin at three different time (day 1, day 4 and day 30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine correlation</measure>
    <time_frame>4 days (day 1, day 4, day 15 and day 30)</time_frame>
    <description>Assess correlation between 12 hours overnight urine and first morning voids samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation melatonin and caffeine</measure>
    <time_frame>4 days (day 1, day 4, day 15 and day 30)</time_frame>
    <description>Assess correlation between the endogenous UMR 6-hydroxymelatonin/melatonin and the paraxanthine/caffeine ratio in dried blood spot (DBS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact caffeine intake</measure>
    <time_frame>1 day (day 15)</time_frame>
    <description>Assess impact of caffeine intake on the UMR 6-hydroxymelatonin/melatonin (day 15) before and after caffeine abstinence (fold-change measurements)</description>
  </secondary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Session 1 (day 1)</intervention_name>
    <description>12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods.&#xD;
After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Session 2 (day 3)</intervention_name>
    <description>12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods.&#xD;
After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Session 3 (day 15)</intervention_name>
    <description>12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to drink or eat caffeinated food/drinks 24 hours prior to night-time urine collection (at least one cup of coffee or a can of Coca-Cola®).&#xD;
After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Session 4 (day 30)</intervention_name>
    <description>12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods.&#xD;
After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  12-hour urine collection during the night (21h-9h) with the first urine in the morning&#xD;
           collected separately&#xD;
&#xD;
        -  capillary blood samples (10 μL)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy men and women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women&#xD;
&#xD;
          -  Understanding of French language and ability to give a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to refrain from alcohol or methylxanthine-containing beverages and foods for&#xD;
             24 hours&#xD;
&#xD;
          -  Sensitivity to coffee or CocaCola®&#xD;
&#xD;
          -  Irregular (i.e. non-daily or inconstant dosages) intake of medication or food of a&#xD;
             CYP1A2 modulator (including tobacco)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Youssef Daali, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geneva University Hospitals</name>
      <address>
        <city>Geneva</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Youssef Daali</investigator_full_name>
    <investigator_title>Professor Youssef Daali</investigator_title>
  </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/NCT04420611
org study id: 2020-00125
nct id: NCT04420611
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
An observational study comprising 4 sessions will be conducted in 12 healthy volunteers.
      During each study session (sessions 1 to 4), a 12-hour urine collection during the night
      (21h-9h) will be carried out by each participant. The first urine in the morning will be
      collected separately to be analysed independently of the 12-hour collection. 24 hours before
      the start of the night urine collection, volunteers will be asked to refrain from consuming
      alcohol and caffeinated drinks/foods, with the exception of session 3. Conversely, in session
      3, subjects will be asked to drink or eat caffeinated food/drinks 24 hours prior to
      night-time urine collection (at least one cup of coffee or a can of Coca-Cola®).

      After each 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of
      coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the
      fingertips 2 hours after the coffee or Coca-Cola®.
observational model: Other
time perspective: Prospective
measure: Validation LC-MS/MS analytical method
time frame: 1 month
description: Validation of the LC-MS/MS analytical method for simultaneous quantification of endogenous melatonin and 6-hydroxymelatonin in urine samples
measure: Intra- and inter-variability
time frame: 3 days (day 1, day 4 and day 30)
description: Assess intra- and inter-variability of the urinary metabolic ratio (UMR) 6-hydroxymelatonin/melatonin at three different time (day 1, day 4 and day 30)
measure: Urine correlation
time frame: 4 days (day 1, day 4, day 15 and day 30)
description: Assess correlation between 12 hours overnight urine and first morning voids samples
measure: Correlation melatonin and caffeine
time frame: 4 days (day 1, day 4, day 15 and day 30)
description: Assess correlation between the endogenous UMR 6-hydroxymelatonin/melatonin and the paraxanthine/caffeine ratio in dried blood spot (DBS)
measure: Impact caffeine intake
time frame: 1 day (day 15)
description: Assess impact of caffeine intake on the UMR 6-hydroxymelatonin/melatonin (day 15) before and after caffeine abstinence (fold-change measurements)
intervention type: Other
intervention name: Session 1 (day 1)
description: 12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods.
After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.
intervention type: Other
intervention name: Session 2 (day 3)
description: 12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods.
After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.
intervention type: Other
intervention name: Session 3 (day 15)
description: 12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to drink or eat caffeinated food/drinks 24 hours prior to night-time urine collection (at least one cup of coffee or a can of Coca-Cola®).
After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.
intervention type: Other
intervention name: Session 4 (day 30)
description: 12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods.
After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.
-  12-hour urine collection during the night (21h-9h) with the first urine in the morning
           collected separately

        -  capillary blood samples (10 μL)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Youssef Daali, Prof
role: Principal Investigator
affiliation: University Hospital, Geneva
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Youssef Daali
investigator title: Professor Youssef Daali