<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/NCT03020134</url>
  </required_header>
  <id_info>
    <org_study_id>ASC162002</org_study_id>
    <nct_id>NCT03020134</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China</brief_title>
  <official_title>Phase I Study of Pharmacokinetics and Safety of Ravidasvir in Combination With Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascletis Pharmaceuticals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ascletis Pharmaceuticals Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in&#xD;
      Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy&#xD;
      Participants&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2016</start_date>
  <completion_date type="Actual">August 22, 2016</completion_date>
  <primary_completion_date type="Actual">August 22, 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>40 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state</measure>
    <time_frame>Up to 24 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PKGroup(Ravidasvir/Danoprevir/Ritonavir)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ravidasvir + Danoprevir/ Ritonavir</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ravidasvir</intervention_name>
    <description>Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23</description>
    <arm_group_label>PKGroup(Ravidasvir/Danoprevir/Ritonavir)</arm_group_label>
    <other_name>ASC16(RDV)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Danoprevir</intervention_name>
    <description>Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23</description>
    <arm_group_label>PKGroup(Ravidasvir/Danoprevir/Ritonavir)</arm_group_label>
    <other_name>ASC08 (DNV)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <description>Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23</description>
    <arm_group_label>PKGroup(Ravidasvir/Danoprevir/Ritonavir)</arm_group_label>
    <other_name>RTV</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  Overall health situation is good according to disease history, physical exam, physical&#xD;
             symptoms, laboratory tests and 12 lead ECG.&#xD;
&#xD;
          -  If female, surgically sterilized or willingness to use reliable method of birth&#xD;
             control during the study and for 30 days after the last dose of study medication.&#xD;
&#xD;
          -  If male, surgically sterilized or willingness to use reliable method of birth control&#xD;
             during the study and for 30 days after the last dose of study medication.&#xD;
&#xD;
          -  If female, negative pregnancy test during the screening period.&#xD;
&#xD;
          -  Others as specified in the detailed protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of cardiovascular disease, respiratory disease, endocrine and&#xD;
             metabolic system disease, urinary system, digestive system, hematological system&#xD;
             diseases, nervous system or Psychiatric diseases, and acute or chronic infectious&#xD;
             disease and malignant tumor.&#xD;
&#xD;
          -  Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab&#xD;
&#xD;
          -  History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other&#xD;
             surgeries that could disturb gastrointestinal motility and PH absorption.&#xD;
&#xD;
          -  Female during pregnancy, breastfeeding, period and unwilling to take reliable birth&#xD;
             control method.&#xD;
&#xD;
          -  Others as specified in the detailed protocol&#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>Huoling Tang, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Ascletis Pharmaceuticals Co., Ltd.</affiliation>
  </overall_official>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>June 27, 2018</last_update_submitted>
  <last_update_submitted_qc>June 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacokinetics</keyword>
  <keyword>Danoprevir/r</keyword>
  <keyword>Ravidasvir</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03020134
org study id: ASC162002
nct id: NCT03020134
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in
      Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy
      Participants
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Safety: Incidence of adverse events
time frame: 40 days
measure: Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
time frame: Up to 24 weeks
measure: Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state
time frame: Up to 24 days
arm group label: PKGroup(Ravidasvir/Danoprevir/Ritonavir)
arm group type: Experimental
description: Ravidasvir + Danoprevir/ Ritonavir
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Ravidasvir
description: Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
arm group label: PKGroup(Ravidasvir/Danoprevir/Ritonavir)
other name: ASC16(RDV)
intervention type: Drug
intervention name: Danoprevir
description: Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
arm group label: PKGroup(Ravidasvir/Danoprevir/Ritonavir)
other name: ASC08 (DNV)
intervention type: Drug
intervention name: Ritonavir
description: Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
arm group label: PKGroup(Ravidasvir/Danoprevir/Ritonavir)
other name: RTV
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Huoling Tang, PhD
role: Study Director
affiliation: Ascletis Pharmaceuticals Co., Ltd.
responsible party type: Sponsor
mesh term: Ritonavir
sharing ipd: No