<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/NCT01728753</url>
  </required_header>
  <id_info>
    <org_study_id>T705aUS213</org_study_id>
    <nct_id>NCT01728753</nct_id>
  </id_info>
  <brief_title>T-705a Multicenter Study in Adults Subjects With Uncomplicated Influenza</brief_title>
  <acronym>FAVOR</acronym>
  <official_title>Randomized, Double Blind,Placebo-Controlled, Multicenter Study Evaluating the Safety and Pharmacokinetics of Different Dosing Regimens of Favipiravir in Healthy Adult Subjects and Adult Subjects With Uncomplicated Influenza</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MDVI, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>MDVI, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age&#xD;
      diagnosed with uncomplicated influenza.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of favipiravir</measure>
    <time_frame>Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve (AUC) of favipiravir</measure>
    <time_frame>Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>time to alleviation of influenza symptoms</measure>
    <time_frame>15 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event[AE]</measure>
    <time_frame>15 days</time_frame>
    <description>The following information will be recorded: AE, time of onset, time of resolution (or note if ongoing), duration of event, severity, relationship to trial medication, use of concomitant medication, and/or other action taken, and action taken with study medication.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">550</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T-705 A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Favipiravir regimen 1: 1200 mg 3x daily (TID) on Day 1, then 600 mg TID on Days 2-5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T-705 B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Favipiravir regimen 2: 2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T-705 C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Favipiravir regimen 3: 1800 mg BID on Day 1, then 800 mg BID for Days 2-5</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo BID x 1 day, and Placebo BID x 4 days; Placebo TID x 1 day, and Placebo TID x 4 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Favipiravir</intervention_name>
    <description>1200 mg TID on Day 1, then 600 mg TID on Days 2-5</description>
    <arm_group_label>T-705 A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Favipiravir</intervention_name>
    <description>2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5</description>
    <arm_group_label>T-705 B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Favipiravir</intervention_name>
    <description>1800 mg BID on Day 1, then 800mg BID for Days 2 5</description>
    <arm_group_label>T-705 C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Understand the requirements of the study and has provided written informed consent&#xD;
             prior to undergoing any study-related procedures.&#xD;
&#xD;
          2. Is male or female between the ages of 18 and 80 years old, inclusive.&#xD;
&#xD;
          3. Tests positive for influenza A or B by a commercially available Rapid Antigen Test&#xD;
             (RAT) -OR- Has influenza confirmed by diagnostic assay (e.g. non-study RAT or PCR)&#xD;
             from another clinic during the 48 hours between onset of symptoms and anticipated&#xD;
             dosing.&#xD;
&#xD;
             (Note: A subject with a negative RAT result may still enroll if the Medical Monitor&#xD;
             and Investigator agree that there is a known influenza outbreak circulating in the&#xD;
             community or the subject has been in close contact with a person who was recently&#xD;
             confirmed to have influenza by RAT or another lab test).&#xD;
&#xD;
          4. Has a fever, defined for subjects ≥18 but ≤65 years old as a temperature (oral) of&#xD;
             100.4°F (38.0°C) or more; subjects &gt;65 years old with a temperature (oral) of 100.0°F&#xD;
             (37.8°C) or more at the first visit or in the 6 hours prior if antipyretics were taken&#xD;
             before the visit.&#xD;
&#xD;
          5. If male, subject must:&#xD;
&#xD;
             a. Be sterile (have had a vasectomy at least 6 months prior to Day 1 dosing and had&#xD;
             sperm counts verifying that he is no longer fertile) OR b. Agree he will not donate&#xD;
             sperm during the study and for 3 months following the last dose of study medication,&#xD;
             and c. Will strictly adhere to the following contraceptive measures for 3 months after&#xD;
             the last dose of study medication: i. Abstain from sexual intercourse or; ii. Use a&#xD;
             condom during sexual intercourse with a female of child-bearing potential. In addition&#xD;
             to the male condom, the female partner must use another form of contraception (e.g.&#xD;
             intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable&#xD;
             progesterone, or subdermal implants) for at least 3 months following Day 1 dosing).&#xD;
&#xD;
          6. If female, subject must:&#xD;
&#xD;
             a. Be unable to bear children (have not had a period for ≥12 consecutive months, have&#xD;
             had her uterus or ovaries removed, or have had a tubal ligation) OR b. Have a male&#xD;
             partner incapable of fathering a child (has had a vasectomy at least 6 months prior to&#xD;
             study entry and has had sperm counts verifying that he is no longer fertile) OR c.&#xD;
             Have a negative urine pregnancy test at screening AND d. Not have had unprotected sex&#xD;
             within the last month AND e. If she is of childbearing potential, will strictly adhere&#xD;
             to the following contraceptive measures during the study and for 3 months following&#xD;
             the last dose of study medication: i. Abstain from sexual intercourse or ii. Her male&#xD;
             partner agrees to use a condom during sexual intercourse AND iii. She agrees to use an&#xD;
             approved method of contraception (e.g., IUD, diaphragm with spermicide, oral&#xD;
             contraceptives, injectable progesterone, or subdermal implants).&#xD;
&#xD;
          7. Has 2 or more of the following symptoms (moderate to severe in intensity) at the time&#xD;
             of enrollment that began 48 hours or less prior to first dose:&#xD;
&#xD;
               1. Cough&#xD;
&#xD;
               2. Sore throat&#xD;
&#xD;
               3. Headache&#xD;
&#xD;
               4. Nasal congestion&#xD;
&#xD;
               5. Body aches and pains&#xD;
&#xD;
               6. Fatigue&#xD;
&#xD;
        Influenza Symptom Intensity:&#xD;
&#xD;
        0: None&#xD;
&#xD;
          1. Mild, Symptoms are tolerable, possible to perform daily activities&#xD;
&#xD;
          2. Moderate, Symptoms are disturbing, partially interfere with daily activities&#xD;
&#xD;
          3. Severe, Symptoms are intolerable, impossible to perform daily activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has taken an anti-influenza drug (e.g., amantadine hydrochloride, rimantadine,&#xD;
             oseltamivir phosphate, zanamivir hydrate, or peramivir) or live vaccination within 4&#xD;
             weeks prior to signing of the informed consent.&#xD;
&#xD;
          2. Has underlying chronic respiratory disease (e.g., Chronic Obstructive Pulmonary&#xD;
             Disease (COPD), chronic bronchitis, diffuse panbronchiolitis, bronchiectasis,&#xD;
             pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or active tuberculosis).&#xD;
&#xD;
          3. At the beginning of the study, is suspected of having bacterial respiratory infection&#xD;
             (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung in a&#xD;
             chest x-ray, or is on antibiotics for lung disease).&#xD;
&#xD;
          4. Has a history of gout or is under treatment for gout or hyperuricemia.&#xD;
&#xD;
          5. Has hereditary xanthinuria.&#xD;
&#xD;
          6. Has a history of hypouricemia (under 1 mg/dL) or xanthine calculi of the urinary&#xD;
             tract.&#xD;
&#xD;
          7. Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a&#xD;
             viral RNA polymerase.&#xD;
&#xD;
          8. Is using adrenocorticosteroids, except topical preparations, or immunosuppressive&#xD;
             drugs (e.g., immunosuppressants, anticancer drugs).&#xD;
&#xD;
          9. Has an allergy to acetaminophen or has a contraindication for acetaminophen.&#xD;
&#xD;
         10. Has a serious chronic disease (e.g., HIV, cancer requiring chemotherapy within the&#xD;
             preceding 6 months, moderate or severe hepatic insufficiency and/or unstable renal,&#xD;
             cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring&#xD;
             medication dose adjustments within the last 30 days).&#xD;
&#xD;
         11. Has previously received favipiravir (T-705a).&#xD;
&#xD;
         12. Has renal insufficiency requiring hemodialysis or central auditory processing disorder&#xD;
             (CAPD).&#xD;
&#xD;
         13. Has a Class II or greater cardiac impairment defined by the New York Heart Association&#xD;
             (NYHA)Functional Classification.&#xD;
&#xD;
         14. Has a history of alcohol or drug abuse in the preceding 2 years.&#xD;
&#xD;
         15. Has a psychiatric disease that is not well controlled (not on a stable regimen for&#xD;
             greater than one year)&#xD;
&#xD;
         16. Has taken another investigational drug within 30 days prior to signing the informed&#xD;
             consent.&#xD;
&#xD;
         17. Is deemed by the Investigator to be ineligible for any reason.&#xD;
&#xD;
         18. Is employed by or is related to an employee of the clinical study site.&#xD;
&#xD;
         19. Female patients who are pregnant, breast-feeding, or have a positive urine pregnancy&#xD;
             test at Visit 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason M Hafizullah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunrise Medical Research, Lauderdale Lakes, FL 33319</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susan Hole, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riverside Clinical Research, Edgewater, FL 32132</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard L. Beasley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Health Concepts, Rapid City, SD 57702</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jay H Sandberg, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oakland Medical Research Center, Troy, MI 48085</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edgardo A. Osea, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Holy Trinity Medical Clinic, Harbor City, CA 90710</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shawn N. Gentry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HCCA Clinical Research Solutions, Columbia, TN 38401</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen K. Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Burke Primary Care, Morganton, NC 28655</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roberto Sotolongo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Institute of South Florida, Inc., Miami, FL 33173</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marina Raikhel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Torrance Clinical Research Institute Inc., Lomita, CA 90717</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Syed M. Rehman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asthma &amp; Allergy Center, Toledo, OH 43617</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Lenz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Integrated Clinca Trial Services Inc., West Des Moines, IA 50265</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jorge L. Santander, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APF Research LLC, Miami, FL 33135</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James A. Cervantes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meridian Clinical Research, Bellevue, NE 68005</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hipolito G. Mariano Jr., MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Center of Fresno, Inc., Fresno, CA 93726</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John M. Wise, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Field of Dreams PC, dba Bozeman Urgent Care Center, Bozeman, MT 59715</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mercedes B. Samson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associated Pharmaceutical Research Center, Inc., Buena Park, CA 90620</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shaukat A. Shah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Medical Associates, Stockton, CA 95204</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Darin Gregory, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pioneer Clinical Research LLC, Bellevue, NE 68005</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sandra M. Gawchik, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asthma and Allergy Research Associates, Upland, PA 19013</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tiffany M. Pluto, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fay West Family Practice, Scottdale, PA 15683</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rennee N. Dhillon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HCCA Clinical Research Solutions, Franklin, TN 37067</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Almena L. Free, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pinnacle Research Group LLC, Anniston, AL 36207</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Esperanza Arce-Nunez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>South Florida Research Phase I-IV, Inc., Miami, FL 33165</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert D. Rosen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Trials of America, Inc., Winston Salem, NC 27103</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Charles M. Schwarz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lovelace Scientific Resources, Inc., Venice, FL 34292</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Idalia A. Acosta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Marcus Research Clinic Inc., Miami, FL 33015</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kishor E. Joshi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cherry Tree Medical Associates/Alternative Clinical Trials LLC, Uniontown, PA 15401</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patricia D. Salvato, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diversified Medical Practices, P.A., Houston, TX 77057</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lawrence P. Schwartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HCCA Clinical Research Solutions, New York, NY 10016</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael C. Hagan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montana Health Research Institute Inc., Billings, MT 59102</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin J. Schear, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dayton Clinical Research, Dayton, OH 45406</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Ong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD Medical Research, Oxon Hill, MD 20745</affiliation>
  </overall_official>
  <overall_official>
    <last_name>April Palmer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Trials Of America Inc., Shreveport, LA 71105</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Derek D. Muse, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Highland Clinical Research, Salt Lake City, UT 84124</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose M. Carpio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Community Research of South Florida, Hialeah, FL 33016</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas M Birch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Holy Name Medical Center, Teaneck, NJ 07666</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Barry K McLean, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cahaba Research, Birmingham, AL 35242</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Barry N Heller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Novo Research Inc., Highland Heights, KY 41076</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karl V Sitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Little Rock Allergy &amp; Asthma Clinical Research Center, Little Rock, AR 72205</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas C Nilsson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Midwest Allergy and Asthma Clinic, P.C., Omaha, NE 68130</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Douglas W Mapel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Trial Connection, Flagstaff, AZ 86001</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronald G DeGarmo, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>DeGarmo Institute of Medical Research, Greer, SC 29651</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Teresa S Sligh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Providence Clinical Research, North Hollywood, CA 91606</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gary L Sutter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HealthCare Partners Medical Group LLC, Los Angeles, CA 90015</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John P Delgado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Integrated Medical Research, PC, Ashland, Oregon 97520</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronald K Stegemoller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>American Health Network of IN, LLC, Avon, IN 46123</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edgar A Marin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Global Clinical Professionals, Miami, FL 33156</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marie R Albert, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Acadia Clinical Research, LLC, Bangor, Maine 04401</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark A Turner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advanced Clinical Research Inc., Meridian, ID 83642</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Terry L Poling, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heartland Research Associates, LLC, Wichita, KS 67207</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David R Hassman, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Comprehensive Clinical Research, Berlin, NJ 08009</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William C Simon, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professional Research Network of Kansas, LLC, Wichita, KS 67203</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian K Allen, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin La Crosse, La Crosse, WI 54601</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ernest L Hendrix, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Alabama Research Center LLC, Athens, Alabama 35611</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John A Panuto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HCCA Clinical Research Solutions, Middleburg Heights, OH 44130</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sadia Dar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HCCA Clinical Research Solutions, Smyrna, TN 37167</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael E Hodges, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Central Arkansas Medical Associates, Mountain Home, AZ 72653</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Melanie Hoppers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physicians Quality Care, Jackson, TN 38305</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Khai S Chang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lakeview Medical Research, Summerfield, FL 34491</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arles Perdomo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Best Quality Research, Hialeah, FL 33016</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neerja Misra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quick Care Medical, Hamilton, NJ 08690</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steve Choi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Urgent Care Specialist, LLC DBA Hometown Urgent Care &amp; Occupational Health, Dayton, OH 45432</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregory Pokrywka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRC Clinics, Towson, MD 21204</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miami Research Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <disposition_first_submitted>September 30, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>September 30, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 21, 2015</disposition_first_posted>
  <last_update_submitted>September 30, 2015</last_update_submitted>
  <last_update_submitted_qc>September 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2015</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>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Favipiravir</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01728753
org study id: T705aUS213
nct id: NCT01728753
lead sponsor: 
collaborator: 
has dmc: Yes
This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age
      diagnosed with uncomplicated influenza.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cmax of favipiravir
time frame: Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours
measure: Area Under the Curve (AUC) of favipiravir
time frame: Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours
measure: time to alleviation of influenza symptoms
time frame: 15 days
measure: Adverse Event[AE]
time frame: 15 days
description: The following information will be recorded: AE, time of onset, time of resolution (or note if ongoing), duration of event, severity, relationship to trial medication, use of concomitant medication, and/or other action taken, and action taken with study medication.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
arm group label: T-705 A
arm group type: Experimental
description: Favipiravir regimen 1: 1200 mg 3x daily (TID) on Day 1, then 600 mg TID on Days 2-5
arm group label: T-705 B
arm group type: Experimental
description: Favipiravir regimen 2: 2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5
arm group label: T-705 C
arm group type: Experimental
description: Favipiravir regimen 3: 1800 mg BID on Day 1, then 800 mg BID for Days 2-5
intervention type: Drug
intervention name: Placebo
description: Placebo BID x 1 day, and Placebo BID x 4 days; Placebo TID x 1 day, and Placebo TID x 4 days
arm group label: Placebo
intervention type: Drug
intervention name: Favipiravir
description: 1200 mg TID on Day 1, then 600 mg TID on Days 2-5
arm group label: T-705 A
intervention type: Drug
intervention name: Favipiravir
description: 2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5
arm group label: T-705 B
intervention type: Drug
intervention name: Favipiravir
description: 1800 mg BID on Day 1, then 800mg BID for Days 2 5
arm group label: T-705 C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jason M Hafizullah, MD
role: Principal Investigator
affiliation: Sunrise Medical Research, Lauderdale Lakes, FL 33319
last name: Susan Hole, D.O.
role: Principal Investigator
affiliation: Riverside Clinical Research, Edgewater, FL 32132
last name: Richard L. Beasley, MD
role: Principal Investigator
affiliation: Health Concepts, Rapid City, SD 57702
last name: Jay H Sandberg, DO
role: Principal Investigator
affiliation: Oakland Medical Research Center, Troy, MI 48085
last name: Edgardo A. Osea, MD
role: Principal Investigator
affiliation: Holy Trinity Medical Clinic, Harbor City, CA 90710
last name: Shawn N. Gentry, MD
role: Principal Investigator
affiliation: HCCA Clinical Research Solutions, Columbia, TN 38401
last name: Stephen K. Smith, MD
role: Principal Investigator
affiliation: Burke Primary Care, Morganton, NC 28655
last name: Roberto Sotolongo, MD
role: Principal Investigator
affiliation: Research Institute of South Florida, Inc., Miami, FL 33173
last name: Marina Raikhel, MD
role: Principal Investigator
affiliation: Torrance Clinical Research Institute Inc., Lomita, CA 90717
last name: Syed M. Rehman, MD
role: Principal Investigator
affiliation: Asthma & Allergy Center, Toledo, OH 43617
last name: Jeffrey Lenz, MD
role: Principal Investigator
affiliation: Integrated Clinca Trial Services Inc., West Des Moines, IA 50265
last name: Jorge L. Santander, MD
role: Principal Investigator
affiliation: APF Research LLC, Miami, FL 33135
last name: James A. Cervantes, MD
role: Principal Investigator
affiliation: Meridian Clinical Research, Bellevue, NE 68005
last name: Hipolito G. Mariano Jr., MD
role: Principal Investigator
affiliation: Research Center of Fresno, Inc., Fresno, CA 93726
last name: John M. Wise, MD
role: Principal Investigator
affiliation: Field of Dreams PC, dba Bozeman Urgent Care Center, Bozeman, MT 59715
last name: Mercedes B. Samson, MD
role: Principal Investigator
affiliation: Associated Pharmaceutical Research Center, Inc., Buena Park, CA 90620
last name: Shaukat A. Shah, MD
role: Principal Investigator
affiliation: St. Joseph's Medical Associates, Stockton, CA 95204
last name: Darin Gregory, MD
role: Principal Investigator
affiliation: Pioneer Clinical Research LLC, Bellevue, NE 68005
last name: Sandra M. Gawchik, DO
role: Principal Investigator
affiliation: Asthma and Allergy Research Associates, Upland, PA 19013
last name: Tiffany M. Pluto, DO
role: Principal Investigator
affiliation: Fay West Family Practice, Scottdale, PA 15683
last name: Rennee N. Dhillon, MD
role: Principal Investigator
affiliation: HCCA Clinical Research Solutions, Franklin, TN 37067
last name: Almena L. Free, MD
role: Principal Investigator
affiliation: Pinnacle Research Group LLC, Anniston, AL 36207
last name: Esperanza Arce-Nunez, MD
role: Principal Investigator
affiliation: South Florida Research Phase I-IV, Inc., Miami, FL 33165
last name: Robert D. Rosen, MD
role: Principal Investigator
affiliation: Clinical Trials of America, Inc., Winston Salem, NC 27103
last name: Charles M. Schwarz, MD
role: Principal Investigator
affiliation: Lovelace Scientific Resources, Inc., Venice, FL 34292
last name: Idalia A. Acosta, MD
role: Principal Investigator
affiliation: San Marcus Research Clinic Inc., Miami, FL 33015
last name: Kishor E. Joshi, MD
role: Principal Investigator
affiliation: Cherry Tree Medical Associates/Alternative Clinical Trials LLC, Uniontown, PA 15401
last name: Patricia D. Salvato, MD
role: Principal Investigator
affiliation: Diversified Medical Practices, P.A., Houston, TX 77057
last name: Lawrence P. Schwartz, MD
role: Principal Investigator
affiliation: HCCA Clinical Research Solutions, New York, NY 10016
last name: Michael C. Hagan, MD
role: Principal Investigator
affiliation: Montana Health Research Institute Inc., Billings, MT 59102
last name: Martin J. Schear, MD
role: Principal Investigator
affiliation: Dayton Clinical Research, Dayton, OH 45406
last name: Stephen Ong, MD
role: Principal Investigator
affiliation: MD Medical Research, Oxon Hill, MD 20745
last name: April Palmer, MD
role: Principal Investigator
affiliation: Clinical Trials Of America Inc., Shreveport, LA 71105
last name: Derek D. Muse, MD
role: Principal Investigator
affiliation: Highland Clinical Research, Salt Lake City, UT 84124
last name: Jose M. Carpio, MD
role: Principal Investigator
affiliation: The Community Research of South Florida, Hialeah, FL 33016
last name: Thomas M Birch, MD
role: Principal Investigator
affiliation: Holy Name Medical Center, Teaneck, NJ 07666
last name: Barry K McLean, MD
role: Principal Investigator
affiliation: Cahaba Research, Birmingham, AL 35242
last name: Barry N Heller, MD
role: Principal Investigator
affiliation: Novo Research Inc., Highland Heights, KY 41076
last name: Karl V Sitz, MD
role: Principal Investigator
affiliation: Little Rock Allergy & Asthma Clinical Research Center, Little Rock, AR 72205
last name: Thomas C Nilsson, MD
role: Principal Investigator
affiliation: Midwest Allergy and Asthma Clinic, P.C., Omaha, NE 68130
last name: Douglas W Mapel, MD
role: Principal Investigator
affiliation: Clinical Trial Connection, Flagstaff, AZ 86001
last name: Ronald G DeGarmo, DO
role: Principal Investigator
affiliation: DeGarmo Institute of Medical Research, Greer, SC 29651
last name: Teresa S Sligh, MD
role: Principal Investigator
affiliation: Providence Clinical Research, North Hollywood, CA 91606
last name: Gary L Sutter, MD
role: Principal Investigator
affiliation: HealthCare Partners Medical Group LLC, Los Angeles, CA 90015
last name: John P Delgado, MD
role: Principal Investigator
affiliation: Integrated Medical Research, PC, Ashland, Oregon 97520
last name: Ronald K Stegemoller, MD
role: Principal Investigator
affiliation: American Health Network of IN, LLC, Avon, IN 46123
last name: Edgar A Marin, MD
role: Principal Investigator
affiliation: Global Clinical Professionals, Miami, FL 33156
last name: Marie R Albert, DO
role: Principal Investigator
affiliation: Acadia Clinical Research, LLC, Bangor, Maine 04401
last name: Mark A Turner, MD
role: Principal Investigator
affiliation: Advanced Clinical Research Inc., Meridian, ID 83642
last name: Terry L Poling, MD
role: Principal Investigator
affiliation: Heartland Research Associates, LLC, Wichita, KS 67207
last name: David R Hassman, DO
role: Principal Investigator
affiliation: Comprehensive Clinical Research, Berlin, NJ 08009
last name: William C Simon, DO
role: Principal Investigator
affiliation: Professional Research Network of Kansas, LLC, Wichita, KS 67203
last name: Brian K Allen, DO
role: Principal Investigator
affiliation: University of Wisconsin La Crosse, La Crosse, WI 54601
last name: Ernest L Hendrix, MD
role: Principal Investigator
affiliation: North Alabama Research Center LLC, Athens, Alabama 35611
last name: John A Panuto, MD
role: Principal Investigator
affiliation: HCCA Clinical Research Solutions, Middleburg Heights, OH 44130
last name: Sadia Dar, MD
role: Principal Investigator
affiliation: HCCA Clinical Research Solutions, Smyrna, TN 37167
last name: Michael E Hodges, MD
role: Principal Investigator
affiliation: North Central Arkansas Medical Associates, Mountain Home, AZ 72653
last name: Melanie Hoppers, MD
role: Principal Investigator
affiliation: Physicians Quality Care, Jackson, TN 38305
last name: Khai S Chang, MD
role: Principal Investigator
affiliation: Lakeview Medical Research, Summerfield, FL 34491
last name: Arles Perdomo, MD
role: Principal Investigator
affiliation: Best Quality Research, Hialeah, FL 33016
last name: Neerja Misra, MD
role: Principal Investigator
affiliation: Quick Care Medical, Hamilton, NJ 08690
last name: Steve Choi, MD
role: Principal Investigator
affiliation: Urgent Care Specialist, LLC DBA Hometown Urgent Care & Occupational Health, Dayton, OH 45432
last name: Gregory Pokrywka, MD
role: Principal Investigator
affiliation: IRC Clinics, Towson, MD 21204
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Favipiravir