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T-705a Multicenter Study in Adults Subjects With Uncomplicated Influenza (FAVOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01728753
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : October 21, 2015
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
MDVI, LLC

Brief Summary:
This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age diagnosed with uncomplicated influenza.

Condition or disease Intervention/treatment Phase
Influenza Drug: Placebo Drug: Favipiravir Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo BID x 1 day, and Placebo BID x 4 days; Placebo TID x 1 day, and Placebo TID x 4 days

Experimental: T-705 A
Favipiravir regimen 1: 1200 mg 3x daily (TID) on Day 1, then 600 mg TID on Days 2-5
Drug: Favipiravir
1200 mg TID on Day 1, then 600 mg TID on Days 2-5

Experimental: T-705 B
Favipiravir regimen 2: 2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5
Drug: Favipiravir
2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5

Experimental: T-705 C
Favipiravir regimen 3: 1800 mg BID on Day 1, then 800 mg BID for Days 2-5
Drug: Favipiravir
1800 mg BID on Day 1, then 800mg BID for Days 2 5




Primary Outcome Measures :
  1. Cmax of favipiravir [ Time Frame: Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours ]
  2. Area Under the Curve (AUC) of favipiravir [ Time Frame: Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours ]

Secondary Outcome Measures :
  1. time to alleviation of influenza symptoms [ Time Frame: 15 days ]
  2. Adverse Event[AE] [ Time Frame: 15 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Understand the requirements of the study and has provided written informed consent prior to undergoing any study-related procedures.
  2. Is male or female between the ages of 18 and 80 years old, inclusive.
  3. Tests positive for influenza A or B by a commercially available Rapid Antigen Test (RAT) -OR- Has influenza confirmed by diagnostic assay (e.g. non-study RAT or PCR) from another clinic during the 48 hours between onset of symptoms and anticipated dosing.

    (Note: A subject with a negative RAT result may still enroll if the Medical Monitor and Investigator agree that there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have influenza by RAT or another lab test).

  4. Has a fever, defined for subjects ≥18 but ≤65 years old as a temperature (oral) of 100.4°F (38.0°C) or more; subjects >65 years old with a temperature (oral) of 100.0°F (37.8°C) or more at the first visit or in the 6 hours prior if antipyretics were taken before the visit.
  5. If male, subject must:

    a. Be sterile (have had a vasectomy at least 6 months prior to Day 1 dosing and had sperm counts verifying that he is no longer fertile) OR b. Agree he will not donate sperm during the study and for 3 months following the last dose of study medication, and c. Will strictly adhere to the following contraceptive measures for 3 months after the last dose of study medication: i. Abstain from sexual intercourse or; ii. Use a condom during sexual intercourse with a female of child-bearing potential. In addition to the male condom, the female partner must use another form of contraception (e.g. intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal implants) for at least 3 months following Day 1 dosing).

  6. If female, subject must:

    a. Be unable to bear children (have not had a period for ≥12 consecutive months, have had her uterus or ovaries removed, or have had a tubal ligation) OR b. Have a male partner incapable of fathering a child (has had a vasectomy at least 6 months prior to study entry and has had sperm counts verifying that he is no longer fertile) OR c. Have a negative urine pregnancy test at screening AND d. Not have had unprotected sex within the last month AND e. If she is of childbearing potential, will strictly adhere to the following contraceptive measures during the study and for 3 months following the last dose of study medication: i. Abstain from sexual intercourse or ii. Her male partner agrees to use a condom during sexual intercourse AND iii. She agrees to use an approved method of contraception (e.g., IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal implants).

  7. Has 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment that began 48 hours or less prior to first dose:

    1. Cough
    2. Sore throat
    3. Headache
    4. Nasal congestion
    5. Body aches and pains
    6. Fatigue

Influenza Symptom Intensity:

0: None

  1. Mild, Symptoms are tolerable, possible to perform daily activities
  2. Moderate, Symptoms are disturbing, partially interfere with daily activities
  3. Severe, Symptoms are intolerable, impossible to perform daily activities

Exclusion Criteria:

  1. Has taken an anti-influenza drug (e.g., amantadine hydrochloride, rimantadine, oseltamivir phosphate, zanamivir hydrate, or peramivir) or live vaccination within 4 weeks prior to signing of the informed consent.
  2. Has underlying chronic respiratory disease (e.g., Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or active tuberculosis).
  3. At the beginning of the study, is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung in a chest x-ray, or is on antibiotics for lung disease).
  4. Has a history of gout or is under treatment for gout or hyperuricemia.
  5. Has hereditary xanthinuria.
  6. Has a history of hypouricemia (under 1 mg/dL) or xanthine calculi of the urinary tract.
  7. Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
  8. Is using adrenocorticosteroids, except topical preparations, or immunosuppressive drugs (e.g., immunosuppressants, anticancer drugs).
  9. Has an allergy to acetaminophen or has a contraindication for acetaminophen.
  10. Has a serious chronic disease (e.g., HIV, cancer requiring chemotherapy within the preceding 6 months, moderate or severe hepatic insufficiency and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days).
  11. Has previously received favipiravir (T-705a).
  12. Has renal insufficiency requiring hemodialysis or central auditory processing disorder (CAPD).
  13. Has a Class II or greater cardiac impairment defined by the New York Heart Association (NYHA)Functional Classification.
  14. Has a history of alcohol or drug abuse in the preceding 2 years.
  15. Has a psychiatric disease that is not well controlled (not on a stable regimen for greater than one year)
  16. Has taken another investigational drug within 30 days prior to signing the informed consent.
  17. Is deemed by the Investigator to be ineligible for any reason.
  18. Is employed by or is related to an employee of the clinical study site.
  19. Female patients who are pregnant, breast-feeding, or have a positive urine pregnancy test at Visit 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728753


Locations
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United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
Sponsors and Collaborators
MDVI, LLC
United States Department of Defense
Investigators
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Principal Investigator: Jason M Hafizullah, MD Sunrise Medical Research, Lauderdale Lakes, FL 33319
Principal Investigator: Susan Hole, D.O. Riverside Clinical Research, Edgewater, FL 32132
Principal Investigator: Richard L. Beasley, MD Health Concepts, Rapid City, SD 57702
Principal Investigator: Jay H Sandberg, DO Oakland Medical Research Center, Troy, MI 48085
Principal Investigator: Edgardo A. Osea, MD Holy Trinity Medical Clinic, Harbor City, CA 90710
Principal Investigator: Shawn N. Gentry, MD HCCA Clinical Research Solutions, Columbia, TN 38401
Principal Investigator: Stephen K. Smith, MD Burke Primary Care, Morganton, NC 28655
Principal Investigator: Roberto Sotolongo, MD Research Institute of South Florida, Inc., Miami, FL 33173
Principal Investigator: Marina Raikhel, MD Torrance Clinical Research Institute Inc., Lomita, CA 90717
Principal Investigator: Syed M. Rehman, MD Asthma & Allergy Center, Toledo, OH 43617
Principal Investigator: Jeffrey Lenz, MD Integrated Clinca Trial Services Inc., West Des Moines, IA 50265
Principal Investigator: Jorge L. Santander, MD APF Research LLC, Miami, FL 33135
Principal Investigator: James A. Cervantes, MD Meridian Clinical Research, Bellevue, NE 68005
Principal Investigator: Hipolito G. Mariano Jr., MD Research Center of Fresno, Inc., Fresno, CA 93726
Principal Investigator: John M. Wise, MD Field of Dreams PC, dba Bozeman Urgent Care Center, Bozeman, MT 59715
Principal Investigator: Mercedes B. Samson, MD Associated Pharmaceutical Research Center, Inc., Buena Park, CA 90620
Principal Investigator: Shaukat A. Shah, MD St. Joseph's Medical Associates, Stockton, CA 95204
Principal Investigator: Darin Gregory, MD Pioneer Clinical Research LLC, Bellevue, NE 68005
Principal Investigator: Sandra M. Gawchik, DO Asthma and Allergy Research Associates, Upland, PA 19013
Principal Investigator: Tiffany M. Pluto, DO Fay West Family Practice, Scottdale, PA 15683
Principal Investigator: Rennee N. Dhillon, MD HCCA Clinical Research Solutions, Franklin, TN 37067
Principal Investigator: Almena L. Free, MD Pinnacle Research Group LLC, Anniston, AL 36207
Principal Investigator: Esperanza Arce-Nunez, MD South Florida Research Phase I-IV, Inc., Miami, FL 33165
Principal Investigator: Robert D. Rosen, MD Clinical Trials of America, Inc., Winston Salem, NC 27103
Principal Investigator: Charles M. Schwarz, MD Lovelace Scientific Resources, Inc., Venice, FL 34292
Principal Investigator: Idalia A. Acosta, MD San Marcus Research Clinic Inc., Miami, FL 33015
Principal Investigator: Kishor E. Joshi, MD Cherry Tree Medical Associates/Alternative Clinical Trials LLC, Uniontown, PA 15401
Principal Investigator: Patricia D. Salvato, MD Diversified Medical Practices, P.A., Houston, TX 77057
Principal Investigator: Lawrence P. Schwartz, MD HCCA Clinical Research Solutions, New York, NY 10016
Principal Investigator: Michael C. Hagan, MD Montana Health Research Institute Inc., Billings, MT 59102
Principal Investigator: Martin J. Schear, MD Dayton Clinical Research, Dayton, OH 45406
Principal Investigator: Stephen Ong, MD MD Medical Research, Oxon Hill, MD 20745
Principal Investigator: April Palmer, MD Clinical Trials Of America Inc., Shreveport, LA 71105
Principal Investigator: Derek D. Muse, MD Highland Clinical Research, Salt Lake City, UT 84124
Principal Investigator: Jose M. Carpio, MD The Community Research of South Florida, Hialeah, FL 33016
Principal Investigator: Thomas M Birch, MD Holy Name Medical Center, Teaneck, NJ 07666
Principal Investigator: Barry K McLean, MD Cahaba Research, Birmingham, AL 35242
Principal Investigator: Barry N Heller, MD Novo Research Inc., Highland Heights, KY 41076
Principal Investigator: Karl V Sitz, MD Little Rock Allergy & Asthma Clinical Research Center, Little Rock, AR 72205
Principal Investigator: Thomas C Nilsson, MD Midwest Allergy and Asthma Clinic, P.C., Omaha, NE 68130
Principal Investigator: Douglas W Mapel, MD Clinical Trial Connection, Flagstaff, AZ 86001
Principal Investigator: Ronald G DeGarmo, DO DeGarmo Institute of Medical Research, Greer, SC 29651
Principal Investigator: Teresa S Sligh, MD Providence Clinical Research, North Hollywood, CA 91606
Principal Investigator: Gary L Sutter, MD HealthCare Partners Medical Group LLC, Los Angeles, CA 90015
Principal Investigator: John P Delgado, MD Integrated Medical Research, PC, Ashland, Oregon 97520
Principal Investigator: Ronald K Stegemoller, MD American Health Network of IN, LLC, Avon, IN 46123
Principal Investigator: Edgar A Marin, MD Global Clinical Professionals, Miami, FL 33156
Principal Investigator: Marie R Albert, DO Acadia Clinical Research, LLC, Bangor, Maine 04401
Principal Investigator: Mark A Turner, MD Advanced Clinical Research Inc., Meridian, ID 83642
Principal Investigator: Terry L Poling, MD Heartland Research Associates, LLC, Wichita, KS 67207
Principal Investigator: David R Hassman, DO Comprehensive Clinical Research, Berlin, NJ 08009
Principal Investigator: William C Simon, DO Professional Research Network of Kansas, LLC, Wichita, KS 67203
Principal Investigator: Brian K Allen, DO University of Wisconsin La Crosse, La Crosse, WI 54601
Principal Investigator: Ernest L Hendrix, MD North Alabama Research Center LLC, Athens, Alabama 35611
Principal Investigator: John A Panuto, MD HCCA Clinical Research Solutions, Middleburg Heights, OH 44130
Principal Investigator: Sadia Dar, MD HCCA Clinical Research Solutions, Smyrna, TN 37167
Principal Investigator: Michael E Hodges, MD North Central Arkansas Medical Associates, Mountain Home, AZ 72653
Principal Investigator: Melanie Hoppers, MD Physicians Quality Care, Jackson, TN 38305
Principal Investigator: Khai S Chang, MD Lakeview Medical Research, Summerfield, FL 34491
Principal Investigator: Arles Perdomo, MD Best Quality Research, Hialeah, FL 33016
Principal Investigator: Neerja Misra, MD Quick Care Medical, Hamilton, NJ 08690
Principal Investigator: Steve Choi, MD Urgent Care Specialist, LLC DBA Hometown Urgent Care & Occupational Health, Dayton, OH 45432
Principal Investigator: Gregory Pokrywka, MD IRC Clinics, Towson, MD 21204
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Responsible Party: MDVI, LLC
ClinicalTrials.gov Identifier: NCT01728753    
Other Study ID Numbers: T705aUS213
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases