<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/NCT01702675</url>
  </required_header>
  <id_info>
    <org_study_id>ACH-HML-01(03/12)</org_study_id>
    <nct_id>NCT01702675</nct_id>
  </id_info>
  <brief_title>Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug</brief_title>
  <acronym>ACH15</acronym>
  <official_title>Phase I, Monocentric, Double-blind, Randomized Study to Assess Tolerability, Safety and Pharmacokinetics of ACH15 After Single Dose and Multiple Doses in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ache Laboratorios Farmaceuticos S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ache Laboratorios Farmaceuticos S.A.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is evaluate the safety and tolerability parameters regarding the&#xD;
      new drug in healthy men and evaluate the pharmacokinetics parameters after one dose and&#xD;
      multiple doses of the new drug.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrocardiogram</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Echocardiography (participants included in Group 6)</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>31 time points up to 2 days</time_frame>
    <description>Blood analysis to evaluate drug pharmacokinetics at Group 1 to 5: 30 minutes and 05 minutes before dose and 00h10 min, 00h15 min, 00h30 min, 00h45 min, 01h, 01h15min, 01h30min, 01h45min, 02h, 02h15min, 02h30min, 02h45min, 03h, 03h15min, 03h30min, 03h45min, 04 h, 04h15min, 04h30min, 04h45min, 05h, 05h30min, 06 h, 08 h, 10 h, 12h, 16h, 24 h e 48hours post-dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High digestive endoscopy (participants included at Group 6)</measure>
    <time_frame>8 days</time_frame>
    <description>Image exam to evaluate the drug safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood analysis</measure>
    <time_frame>30 days</time_frame>
    <description>Blood will be collected to evaluate the drug safety by analysis of biochemical profile</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>67 pint time over 8 days</time_frame>
    <description>Blood analysis to evaluate drug pharmacokinetics at Group 6:00:30 min before dose, 00h20min, 00h40min, 01h, 01h15min, 01h30min, 01h45min, 02h, 02h15min, 02h30min, 02h45min, 03h, 03h15min, 03h30min, 03h45min, 04h, 04h15min, 04h30min, 04h45min, 05h, 05h30min, 06h, 08h, 10h, 12h, 14h, 18h, 24h, 26h, 30h, 36h, 38h, 42h, 48h, 50h, 54h, 60h, 62h, 66h, 72h, 74h, 78h, 84h, 86h, 90h, 96h, 98h, 102h, 108h, 110h, 114h, 120h, 122h, 126h, 132h, 134h, 138h, 144h, 146h, 150h, 156h, 158h, 162h, 168h, 174h, 180h e 192h post-dose.</description>
  </primary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>ACH15 - 50mg capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACH15 50mg capsule by mouth single dose (Group 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACH15 - 250 mg capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACH15 250mg capsule by mouth as single dose(Group 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACH15 - 500mg capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACH15 500mg capsule by mouth in a single dose(Group 3)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACH15 - 1000 mg (two 500mg capsule)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACH15 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACH15 - 2000 mg (four 500 mg capsule)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACH15 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACH15 - 500 mg (twice a day for 7 days)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACH15 500mg capsule by mouth twice a day for seven days (Group 6)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - 250 mg capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 250mg capsule by mouth single dose (Group 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - 500 mg capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 500mg capsule by mouth in a single dose(Group 3)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - 1000 mg (two 500mg capsule)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 2000 mg (four 500mg capsule)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - 500 mg (twice a day for 7 days)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 500mg capsule by mouth twice a day for seven days (Group 7)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACH15 50 mg</intervention_name>
    <description>ACH15 50mg capsule</description>
    <arm_group_label>ACH15 - 50mg capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACH15 250 mg</intervention_name>
    <description>ACH15 250mg capsule</description>
    <arm_group_label>ACH15 - 250 mg capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACH15 500mg</intervention_name>
    <description>ACH15 500 mg capsule</description>
    <arm_group_label>ACH15 - 500mg capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACH15 - 1000mg</intervention_name>
    <description>ACH15 500mg capsule - two 500mg capsules in single dose</description>
    <arm_group_label>ACH15 - 1000 mg (two 500mg capsule)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACH15 - 2000mg</intervention_name>
    <description>ACH15 500mg capsule (four 500mg capsules in one dose)</description>
    <arm_group_label>ACH15 - 2000 mg (four 500 mg capsule)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACH15 - 500mg</intervention_name>
    <description>ACH15 - 500mg twice a day for 7 days</description>
    <arm_group_label>ACH15 - 500 mg (twice a day for 7 days)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo 250 mg</intervention_name>
    <description>Capsule manufactured to mimic ACH15 250 mg capsule</description>
    <arm_group_label>Placebo - 250 mg capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo 500mg</intervention_name>
    <description>Capsule manufactured to mimic ACH15 500 mg capsule</description>
    <arm_group_label>Placebo - 500 mg (twice a day for 7 days)</arm_group_label>
    <arm_group_label>Placebo - 500 mg capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo 1000mg</intervention_name>
    <description>Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)</description>
    <arm_group_label>Placebo - 1000 mg (two 500mg capsule)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo 2000mg</intervention_name>
    <description>Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)</description>
    <arm_group_label>Placebo 2000 mg (four 500mg capsule)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo 500mg</intervention_name>
    <description>Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)</description>
    <arm_group_label>Placebo - 500 mg (twice a day for 7 days)</arm_group_label>
    <arm_group_label>Placebo - 500 mg capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patient, aged between 18 and 50 years;&#xD;
&#xD;
          -  Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and ≤ 30 kg/m2;&#xD;
&#xD;
          -  Healthy men accordance with their historical and tests;&#xD;
&#xD;
          -  Healthy subject with laboratory results within the normal range or within the&#xD;
             parameters accepted by the clinical protocol&#xD;
&#xD;
          -  Negative results for parasitological stool examination performed in the clinical&#xD;
             study;&#xD;
&#xD;
          -  Subject of research with laboratory results within the normal range for urinalysis&#xD;
             collected before the first visit;&#xD;
&#xD;
          -  Research subjects allocated in Group 6 with endoscopy within the normal range;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of gastrointestinal disease, hepatic, renal, cardiovascular, pulmonary,&#xD;
             neurologic, hematologic, diabetes or glaucoma;&#xD;
&#xD;
          -  Evidence on clinical examination or physical or complement, organ dysfunction or any&#xD;
             clinically significant deviation from normality;&#xD;
&#xD;
          -  History of use of psychotropic drugs or excessive alcohol consumption (more than two&#xD;
             units of alcohol per day, one unit being equivalent to one cup (200 mL) of brew or a&#xD;
             dose (50) mL of distilled beverage) or having difficulty to abstain during the study;&#xD;
&#xD;
          -  Use of any medication two (2) weeks prior to inclusion of the research subject in the&#xD;
             study;&#xD;
&#xD;
          -  Regular smokers or who quit less than one (1) year;&#xD;
&#xD;
          -  History of food allergy or hyperreactivity to medications or foods;&#xD;
&#xD;
          -  HIV positive for HIV;&#xD;
&#xD;
          -  Being positive for Hepatitis B;&#xD;
&#xD;
          -  Being positive for hepatitis C;&#xD;
&#xD;
          -  Testing positive for Helicobacter pilorum;&#xD;
&#xD;
          -  Using substances modulating hepatic microsomal activity within thirty (30) days prior&#xD;
             to entry of the subject of research in the clinical study (date of signing the consent&#xD;
             form);&#xD;
&#xD;
          -  Having donated blood (blood volume higher than 500 mL) within four (4) months&#xD;
             preceding the date of signing the consent form;&#xD;
&#xD;
          -  Subject with a history of hypersensitivity to any component of the investigational&#xD;
             product;&#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>
  <overall_official>
    <last_name>Sérgio Vencio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICF - Instituto de Ciências Farmacêuticas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICF - Instituto de Ciências Farmacêuticas</name>
      <address>
        <city>Aparecida de Goiânia</city>
        <state>Goiás</state>
        <zip>74935-530</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>October 27, 2016</last_update_submitted>
  <last_update_submitted_qc>October 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Safety</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Tolerability</keyword>
  <keyword>Healthy men</keyword>
  <!-- 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/NCT01702675
org study id: ACH-HML-01(03/12)
nct id: NCT01702675
lead sponsor: 
has dmc: Yes
The purpose of this study is evaluate the safety and tolerability parameters regarding the
      new drug in healthy men and evaluate the pharmacokinetics parameters after one dose and
      multiple doses of the new drug.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Blood pressure
time frame: 30 days
measure: Electrocardiogram
time frame: 30 days
measure: Echocardiography (participants included in Group 6)
time frame: 30 days
measure: Cmax
time frame: 31 time points up to 2 days
description: Blood analysis to evaluate drug pharmacokinetics at Group 1 to 5: 30 minutes and 05 minutes before dose and 00h10 min, 00h15 min, 00h30 min, 00h45 min, 01h, 01h15min, 01h30min, 01h45min, 02h, 02h15min, 02h30min, 02h45min, 03h, 03h15min, 03h30min, 03h45min, 04 h, 04h15min, 04h30min, 04h45min, 05h, 05h30min, 06 h, 08 h, 10 h, 12h, 16h, 24 h e 48hours post-dose
measure: High digestive endoscopy (participants included at Group 6)
time frame: 8 days
description: Image exam to evaluate the drug safety
measure: Blood analysis
time frame: 30 days
description: Blood will be collected to evaluate the drug safety by analysis of biochemical profile
measure: Cmax
time frame: 67 pint time over 8 days
description: Blood analysis to evaluate drug pharmacokinetics at Group 6:00:30 min before dose, 00h20min, 00h40min, 01h, 01h15min, 01h30min, 01h45min, 02h, 02h15min, 02h30min, 02h45min, 03h, 03h15min, 03h30min, 03h45min, 04h, 04h15min, 04h30min, 04h45min, 05h, 05h30min, 06h, 08h, 10h, 12h, 14h, 18h, 24h, 26h, 30h, 36h, 38h, 42h, 48h, 50h, 54h, 60h, 62h, 66h, 72h, 74h, 78h, 84h, 86h, 90h, 96h, 98h, 102h, 108h, 110h, 114h, 120h, 122h, 126h, 132h, 134h, 138h, 144h, 146h, 150h, 156h, 158h, 162h, 168h, 174h, 180h e 192h post-dose.
arm group label: ACH15 - 50mg capsule
arm group type: Experimental
description: ACH15 50mg capsule by mouth single dose (Group 1)
arm group label: ACH15 - 250 mg capsule
arm group type: Experimental
description: ACH15 250mg capsule by mouth as single dose(Group 2)
arm group label: ACH15 - 500mg capsule
arm group type: Experimental
description: ACH15 500mg capsule by mouth in a single dose(Group 3)
arm group label: ACH15 - 1000 mg (two 500mg capsule)
arm group type: Experimental
description: ACH15 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
arm group label: ACH15 - 2000 mg (four 500 mg capsule)
arm group type: Experimental
description: ACH15 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
arm group label: ACH15 - 500 mg (twice a day for 7 days)
arm group type: Experimental
description: ACH15 500mg capsule by mouth twice a day for seven days (Group 6)
arm group label: Placebo - 250 mg capsule
arm group type: Placebo Comparator
description: Placebo 250mg capsule by mouth single dose (Group 2)
arm group label: Placebo - 500 mg capsule
arm group type: Placebo Comparator
description: Placebo 500mg capsule by mouth in a single dose(Group 3)
arm group label: Placebo - 1000 mg (two 500mg capsule)
arm group type: Placebo Comparator
description: Placebo 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
arm group label: Placebo 2000 mg (four 500mg capsule)
arm group type: Placebo Comparator
description: Placebo 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
arm group label: Placebo - 500 mg (twice a day for 7 days)
arm group type: Placebo Comparator
description: Placebo 500mg capsule by mouth twice a day for seven days (Group 7)
intervention type: Drug
intervention name: ACH15 50 mg
description: ACH15 50mg capsule
arm group label: ACH15 - 50mg capsule
intervention type: Drug
intervention name: ACH15 250 mg
description: ACH15 250mg capsule
arm group label: ACH15 - 250 mg capsule
intervention type: Drug
intervention name: ACH15 500mg
description: ACH15 500 mg capsule
arm group label: ACH15 - 500mg capsule
intervention type: Drug
intervention name: ACH15 - 1000mg
description: ACH15 500mg capsule - two 500mg capsules in single dose
arm group label: ACH15 - 1000 mg (two 500mg capsule)
intervention type: Drug
intervention name: ACH15 - 2000mg
description: ACH15 500mg capsule (four 500mg capsules in one dose)
arm group label: ACH15 - 2000 mg (four 500 mg capsule)
intervention type: Drug
intervention name: ACH15 - 500mg
description: ACH15 - 500mg twice a day for 7 days
arm group label: ACH15 - 500 mg (twice a day for 7 days)
intervention type: Drug
intervention name: Placebo 250 mg
description: Capsule manufactured to mimic ACH15 250 mg capsule
arm group label: Placebo - 250 mg capsule
intervention type: Drug
intervention name: Placebo 500mg
description: Capsule manufactured to mimic ACH15 500 mg capsule
arm group label: Placebo - 500 mg (twice a day for 7 days)
arm group label: Placebo - 500 mg capsule
intervention type: Drug
intervention name: Placebo 1000mg
description: Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)
arm group label: Placebo - 1000 mg (two 500mg capsule)
intervention type: Drug
intervention name: Placebo 2000mg
description: Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)
arm group label: Placebo 2000 mg (four 500mg capsule)
intervention type: Drug
intervention name: Placebo 500mg
description: Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)
arm group label: Placebo - 500 mg (twice a day for 7 days)
arm group label: Placebo - 500 mg capsule
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sérgio Vencio, MD
role: Principal Investigator
affiliation: ICF - Instituto de Ciências Farmacêuticas
facility: 
country: Brazil
responsible party type: Sponsor