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

NCT ID: NCT01728753

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-02-28

Brief Summary

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

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

T-705 A

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

Group Type: EXPERIMENTAL

Favipiravir

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Favipiravir

Intervention Type: DRUG

2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5

T-705 C

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

Group Type: EXPERIMENTAL

Favipiravir

Intervention Type: DRUG

1800 mg BID on Day 1, then 800mg BID for Days 2 5

Interventions

Placebo

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

Intervention Type: DRUG

Favipiravir

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

Intervention Type: DRUG

Favipiravir

2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5

Intervention Type: DRUG

Favipiravir

1800 mg BID on Day 1, then 800mg BID for Days 2 5

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

MDVI, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason M Hafizullah, MD

Role: PRINCIPAL_INVESTIGATOR

Sunrise Medical Research, Lauderdale Lakes, FL 33319

Susan Hole, D.O.

Role: PRINCIPAL_INVESTIGATOR

Riverside Clinical Research, Edgewater, FL 32132

Richard L. Beasley, MD

Role: PRINCIPAL_INVESTIGATOR

Health Concepts, Rapid City, SD 57702

Jay H Sandberg, DO

Role: PRINCIPAL_INVESTIGATOR

Oakland Medical Research Center, Troy, MI 48085

Edgardo A. Osea, MD

Role: PRINCIPAL_INVESTIGATOR

Holy Trinity Medical Clinic, Harbor City, CA 90710

Shawn N. Gentry, MD

Role: PRINCIPAL_INVESTIGATOR

HCCA Clinical Research Solutions, Columbia, TN 38401

Stephen K. Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Burke Primary Care, Morganton, NC 28655

Roberto Sotolongo, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute of South Florida, Inc., Miami, FL 33173

Marina Raikhel, MD

Role: PRINCIPAL_INVESTIGATOR

Torrance Clinical Research Institute Inc., Lomita, CA 90717

Syed M. Rehman, MD

Role: PRINCIPAL_INVESTIGATOR

Asthma & Allergy Center, Toledo, OH 43617

Jeffrey Lenz, MD

Role: PRINCIPAL_INVESTIGATOR

Integrated Clinca Trial Services Inc., West Des Moines, IA 50265

Jorge L. Santander, MD

Role: PRINCIPAL_INVESTIGATOR

APF Research LLC, Miami, FL 33135

James A. Cervantes, MD

Role: PRINCIPAL_INVESTIGATOR

Meridian Clinical Research, Bellevue, NE 68005

Hipolito G. Mariano Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Research Center of Fresno, Inc., Fresno, CA 93726

John M. Wise, MD

Role: PRINCIPAL_INVESTIGATOR

Field of Dreams PC, dba Bozeman Urgent Care Center, Bozeman, MT 59715

Mercedes B. Samson, MD

Role: PRINCIPAL_INVESTIGATOR

Associated Pharmaceutical Research Center, Inc., Buena Park, CA 90620

Shaukat A. Shah, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Medical Associates, Stockton, CA 95204

Darin Gregory, MD

Role: PRINCIPAL_INVESTIGATOR

Pioneer Clinical Research LLC, Bellevue, NE 68005

Sandra M. Gawchik, DO

Role: PRINCIPAL_INVESTIGATOR

Asthma and Allergy Research Associates, Upland, PA 19013

Tiffany M. Pluto, DO

Role: PRINCIPAL_INVESTIGATOR

Fay West Family Practice, Scottdale, PA 15683

Rennee N. Dhillon, MD

Role: PRINCIPAL_INVESTIGATOR

HCCA Clinical Research Solutions, Franklin, TN 37067

Almena L. Free, MD

Role: PRINCIPAL_INVESTIGATOR

Pinnacle Research Group LLC, Anniston, AL 36207

Esperanza Arce-Nunez, MD

Role: PRINCIPAL_INVESTIGATOR

South Florida Research Phase I-IV, Inc., Miami, FL 33165

Robert D. Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trials of America, Inc., Winston Salem, NC 27103

Charles M. Schwarz, MD

Role: PRINCIPAL_INVESTIGATOR

Lovelace Scientific Resources, Inc., Venice, FL 34292

Idalia A. Acosta, MD

Role: PRINCIPAL_INVESTIGATOR

San Marcus Research Clinic Inc., Miami, FL 33015

Kishor E. Joshi, MD

Role: PRINCIPAL_INVESTIGATOR

Cherry Tree Medical Associates/Alternative Clinical Trials LLC, Uniontown, PA 15401

Patricia D. Salvato, MD

Role: PRINCIPAL_INVESTIGATOR

Diversified Medical Practices, P.A., Houston, TX 77057

Lawrence P. Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

HCCA Clinical Research Solutions, New York, NY 10016

Michael C. Hagan, MD

Role: PRINCIPAL_INVESTIGATOR

Montana Health Research Institute Inc., Billings, MT 59102

Martin J. Schear, MD

Role: PRINCIPAL_INVESTIGATOR

Dayton Clinical Research, Dayton, OH 45406

Stephen Ong, MD

Role: PRINCIPAL_INVESTIGATOR

MD Medical Research, Oxon Hill, MD 20745

April Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trials Of America Inc., Shreveport, LA 71105

Derek D. Muse, MD

Role: PRINCIPAL_INVESTIGATOR

Highland Clinical Research, Salt Lake City, UT 84124

Jose M. Carpio, MD

Role: PRINCIPAL_INVESTIGATOR

The Community Research of South Florida, Hialeah, FL 33016

Thomas M Birch, MD

Role: PRINCIPAL_INVESTIGATOR

Holy Name Medical Center, Teaneck, NJ 07666

Barry K McLean, MD

Role: PRINCIPAL_INVESTIGATOR

Cahaba Research, Birmingham, AL 35242

Barry N Heller, MD

Role: PRINCIPAL_INVESTIGATOR

Novo Research Inc., Highland Heights, KY 41076

Karl V Sitz, MD

Role: PRINCIPAL_INVESTIGATOR

Little Rock Allergy & Asthma Clinical Research Center, Little Rock, AR 72205

Thomas C Nilsson, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Allergy and Asthma Clinic, P.C., Omaha, NE 68130

Douglas W Mapel, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Connection, Flagstaff, AZ 86001

Ronald G DeGarmo, DO

Role: PRINCIPAL_INVESTIGATOR

DeGarmo Institute of Medical Research, Greer, SC 29651

Teresa S Sligh, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Clinical Research, North Hollywood, CA 91606

Gary L Sutter, MD

Role: PRINCIPAL_INVESTIGATOR

HealthCare Partners Medical Group LLC, Los Angeles, CA 90015

John P Delgado, MD

Role: PRINCIPAL_INVESTIGATOR

Integrated Medical Research, PC, Ashland, Oregon 97520

Ronald K Stegemoller, MD

Role: PRINCIPAL_INVESTIGATOR

American Health Network of IN, LLC, Avon, IN 46123

Edgar A Marin, MD

Role: PRINCIPAL_INVESTIGATOR

Global Clinical Professionals, Miami, FL 33156

Marie R Albert, DO

Role: PRINCIPAL_INVESTIGATOR

Acadia Clinical Research, LLC, Bangor, Maine 04401

Mark A Turner, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Clinical Research Inc., Meridian, ID 83642

Terry L Poling, MD

Role: PRINCIPAL_INVESTIGATOR

Heartland Research Associates, LLC, Wichita, KS 67207

David R Hassman, DO

Role: PRINCIPAL_INVESTIGATOR

Comprehensive Clinical Research, Berlin, NJ 08009

William C Simon, DO

Role: PRINCIPAL_INVESTIGATOR

Professional Research Network of Kansas, LLC, Wichita, KS 67203

Brian K Allen, DO

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin La Crosse, La Crosse, WI 54601

Ernest L Hendrix, MD

Role: PRINCIPAL_INVESTIGATOR

North Alabama Research Center LLC, Athens, Alabama 35611

John A Panuto, MD

Role: PRINCIPAL_INVESTIGATOR

HCCA Clinical Research Solutions, Middleburg Heights, OH 44130

Sadia Dar, MD

Role: PRINCIPAL_INVESTIGATOR

HCCA Clinical Research Solutions, Smyrna, TN 37167

Michael E Hodges, MD

Role: PRINCIPAL_INVESTIGATOR

North Central Arkansas Medical Associates, Mountain Home, AZ 72653

Melanie Hoppers, MD

Role: PRINCIPAL_INVESTIGATOR

Physicians Quality Care, Jackson, TN 38305

Khai S Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Lakeview Medical Research, Summerfield, FL 34491

Arles Perdomo, MD

Role: PRINCIPAL_INVESTIGATOR

Best Quality Research, Hialeah, FL 33016

Neerja Misra, MD

Role: PRINCIPAL_INVESTIGATOR

Quick Care Medical, Hamilton, NJ 08690

Steve Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Urgent Care Specialist, LLC DBA Hometown Urgent Care & Occupational Health, Dayton, OH 45432

Gregory Pokrywka, MD

Role: PRINCIPAL_INVESTIGATOR

IRC Clinics, Towson, MD 21204

Locations

Miami Research Associates

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37739792 (View on PubMed)

Other Identifiers

T705aUS213

Identifier Type: -

Identifier Source: org_study_id