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

NCT01728753 | Completed Phase 1 DMC

• 1 other identifier: T705aUS213
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• Cmax of favipiravir

  Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours

• Area Under the Curve (AUC) of favipiravir

  Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours

Secondary Outcomes (2)

• time to alleviation of influenza symptoms

  15 days

• Adverse Event[AE]

  15 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

T-705 A

EXPERIMENTAL

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

Drug: Favipiravir

T-705 B

EXPERIMENTAL

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

T-705 C

EXPERIMENTAL

Favipiravir regimen 3: 1800 mg BID on Day 1, then 800 mg BID for Days 2-5

Drug: Favipiravir

Interventions

Placebo DRUG

Placebo BID x 1 day, and Placebo BID x 4 days; Placebo TID x 1 day, and Placebo TID x 4 days

Placebo

Favipiravir DRUG

1200 mg TID on Day 1, then 600 mg TID on Days 2-5

T-705 A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the requirements of the study and has provided written informed consent prior to undergoing any study-related procedures.
• Is male or female between the ages of 18 and 80 years old, inclusive.
• 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).
• 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.
• 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).
• 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).
• 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:
• Cough
• Sore throat
• Headache
• Nasal congestion
• Body aches and pains

You may not qualify if:

• 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.
• 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).
• 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).
• Has a history of gout or is under treatment for gout or hyperuricemia.
• Has hereditary xanthinuria.
• Has a history of hypouricemia (under 1 mg/dL) or xanthine calculi of the urinary tract.
• Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
• Is using adrenocorticosteroids, except topical preparations, or immunosuppressive drugs (e.g., immunosuppressants, anticancer drugs).
• Has an allergy to acetaminophen or has a contraindication for acetaminophen.
• 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).
• Has previously received favipiravir (T-705a).
• Has renal insufficiency requiring hemodialysis or central auditory processing disorder (CAPD).
• Has a Class II or greater cardiac impairment defined by the New York Heart Association (NYHA)Functional Classification.
• Has a history of alcohol or drug abuse in the preceding 2 years.
• Has a psychiatric disease that is not well controlled (not on a stable regimen for greater than one year)

Sponsors & Collaborators

• MDVI, LLC: lead
• United States Department of Defense: collaborator

Study Sites (1)

Miami Research Associates

Miami, Florida, 33143, United States

Location

Related Publications (1)

• Hayden FG, Lenk RP, Epstein C, Kang LL. Oral Favipiravir Exposure and Pharmacodynamic Effects in Adult Outpatients With Acute Influenza. J Infect Dis. 2024 Aug 16;230(2):e395-e404. doi: 10.1093/infdis/jiad409.

  PMID: 37739792 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

favipiravir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 20, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 21, 2015

Record last verified: 2015-09

Locations

US (1)