<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/NCT02986529</url>
  </required_header>
  <id_info>
    <org_study_id>CRC-C1503</org_study_id>
    <nct_id>NCT02986529</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects</brief_title>
  <official_title>A Double-blind, Randomized, Three-period, Three-way Crossover Design, Placebo Controlled Single Dose Study to Assess the Bioavailability of Sodium Oligo-mannurarate (GV-971) Capsule 150 mg, 300mg, 450mg in Healthy Chinese Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Greenvalley Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Greenvalley Pharmaceutical Co., Ltd.</source>
  <brief_summary>
    <textblock>
      To evaluate the Bioavailability for GV-971 capsules of 150 mg, 300mg, and 450mg after&#xD;
      administration of single oral doses of 900mg in healthy Male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">February 24, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last-the area under the concentration-time curve from zero to the time of the last measurable concentration; computed using the linear trapezoidal rule</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞-the area under the concentration-time curve from zero to the infinity, computed as AUC0-∞=AUC0-last+Clast/λz (λz is the terminal phase rate constant)</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Bioavailability</condition>
  <arm_group>
    <arm_group_label>GV-971 150mg/capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>900mg, oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GV-971 300mg/capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>900mg, oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GV-971 450mg/capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>900mg, oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GV-971</intervention_name>
    <arm_group_label>GV-971 150mg/capsule</arm_group_label>
    <arm_group_label>GV-971 300mg/capsule</arm_group_label>
    <arm_group_label>GV-971 450mg/capsule</arm_group_label>
    <other_name>Sodium Oligo-mannurarate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male subjects;&#xD;
&#xD;
          2. Age：≥18 and ≤45 on the date signing informed consent&#xD;
&#xD;
          3. Body mass index (BMI): 18-25 kg/m2 and the weight ≥50 kg；&#xD;
&#xD;
          4. Subjects are able to understand the study procedures and methods, and willing to&#xD;
             strictly comply with the protocol and give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A subject will be excluded if the answer to any of the following criteria is &quot;yes&quot;:：&#xD;
&#xD;
          1. Clinically significant abnormalities in physical examination and laboratory test&#xD;
             results or 12-lead ECG, etc. in screening;&#xD;
&#xD;
          2. Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound&#xD;
             examination&#xD;
&#xD;
          3. Positive serology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR&#xD;
             unheated serum reagin test.&#xD;
&#xD;
          4. Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to&#xD;
             screening&#xD;
&#xD;
          5. Participation in any investigational drug or medical instrument study within 3months&#xD;
             prior to screening, participation in 3 and more than 3 drug tests in a recent year;&#xD;
&#xD;
          6. Serious infection, trauma and major surgery within 4weeks prior to screening;&#xD;
&#xD;
          7. Blood donation of ≥400 mL or severe blood lose and the volume of blood loss ≥400 mL&#xD;
             within 4 weeks prior to screening, receiving blood transfusion treatment within 8&#xD;
             weeks prior to screening ;&#xD;
&#xD;
          8. Use of any prescription medicine or herbal remedy, over the counter medication or&#xD;
             dietary supplements such as vitamin, calcium within 2 weeks prior to screening.&#xD;
&#xD;
          9. Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to&#xD;
             screening；&#xD;
&#xD;
         10. Vegetarian or person with dietary restrictions&#xD;
&#xD;
         11. Subjects able to father a child are unwilling to use highly effective physical form of&#xD;
             birth control from the trial period until 3 months after the completion of study.&#xD;
&#xD;
         12. With diseases which could impact on the absorption, distribution, metabolism and&#xD;
             excretion (ADME) of study drugs or protocol adherence in the opinion of the&#xD;
             investigator (such medical disorder/disease may relate to ccardiovascular, liver,&#xD;
             kidney, digestive, immune, blood, endocrine, metabolic, cancer, neuropsychiatric,etc&#xD;
             );&#xD;
&#xD;
         13. Subjects may be allergic to GV-971 in the opinion of the investigator.&#xD;
&#xD;
         14. Any other reasons that the subject is not eligible for participation in the study in&#xD;
             the opinion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02986529
org study id: CRC-C1503
nct id: NCT02986529
lead sponsor: 
To evaluate the Bioavailability for GV-971 capsules of 150 mg, 300mg, and 450mg after
      administration of single oral doses of 900mg in healthy Male subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve
time frame: 3 days
measure: AUC0-last-the area under the concentration-time curve from zero to the time of the last measurable concentration; computed using the linear trapezoidal rule
time frame: 3 days
measure: AUC0-∞-the area under the concentration-time curve from zero to the infinity, computed as AUC0-∞=AUC0-last+Clast/λz (λz is the terminal phase rate constant)
time frame: 3 days
arm group label: GV-971 150mg/capsule
arm group type: Active Comparator
description: 900mg, oral
arm group label: GV-971 300mg/capsule
arm group type: Experimental
description: 900mg, oral
arm group label: GV-971 450mg/capsule
arm group type: Experimental
description: 900mg, oral
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral
intervention type: Drug
intervention name: GV-971
arm group label: GV-971 150mg/capsule
arm group label: GV-971 300mg/capsule
arm group label: GV-971 450mg/capsule
other name: Sodium Oligo-mannurarate
intervention type: Drug
intervention name: Placebos
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor