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

Summary

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

Conditions

• Influenza

Interventions

DRUG

Placebo

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

DRUG

Favipiravir

1200 mg TID 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

DRUG

Favipiravir

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

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• MDVI, LLC

  lead INDUSTRY

Principal Investigators

• Jason M Hafizullah, MD · Sunrise Medical Research, Lauderdale Lakes, FL 33319

• Susan Hole, D.O. · Riverside Clinical Research, Edgewater, FL 32132

• Richard L. Beasley, MD · Health Concepts, Rapid City, SD 57702

• Jay H Sandberg, DO · Oakland Medical Research Center, Troy, MI 48085

• Edgardo A. Osea, MD · Holy Trinity Medical Clinic, Harbor City, CA 90710

• Shawn N. Gentry, MD · HCCA Clinical Research Solutions, Columbia, TN 38401

• Stephen K. Smith, MD · Burke Primary Care, Morganton, NC 28655

• Roberto Sotolongo, MD · Research Institute of South Florida, Inc., Miami, FL 33173

• Marina Raikhel, MD · Torrance Clinical Research Institute Inc., Lomita, CA 90717

• Syed M. Rehman, MD · Asthma & Allergy Center, Toledo, OH 43617

• Jeffrey Lenz, MD · Integrated Clinca Trial Services Inc., West Des Moines, IA 50265

• Jorge L. Santander, MD · APF Research LLC, Miami, FL 33135

• James A. Cervantes, MD · Meridian Clinical Research, Bellevue, NE 68005

• Hipolito G. Mariano Jr., MD · Research Center of Fresno, Inc., Fresno, CA 93726

• John M. Wise, MD · Field of Dreams PC, dba Bozeman Urgent Care Center, Bozeman, MT 59715

• Mercedes B. Samson, MD · Associated Pharmaceutical Research Center, Inc., Buena Park, CA 90620

• Shaukat A. Shah, MD · St. Joseph's Medical Associates, Stockton, CA 95204

• Darin Gregory, MD · Pioneer Clinical Research LLC, Bellevue, NE 68005

• Sandra M. Gawchik, DO · Asthma and Allergy Research Associates, Upland, PA 19013

• Tiffany M. Pluto, DO · Fay West Family Practice, Scottdale, PA 15683

• Rennee N. Dhillon, MD · HCCA Clinical Research Solutions, Franklin, TN 37067

• Almena L. Free, MD · Pinnacle Research Group LLC, Anniston, AL 36207

• Esperanza Arce-Nunez, MD · South Florida Research Phase I-IV, Inc., Miami, FL 33165

• Robert D. Rosen, MD · Clinical Trials of America, Inc., Winston Salem, NC 27103

• Charles M. Schwarz, MD · Lovelace Scientific Resources, Inc., Venice, FL 34292

• Idalia A. Acosta, MD · San Marcus Research Clinic Inc., Miami, FL 33015

• Kishor E. Joshi, MD · Cherry Tree Medical Associates/Alternative Clinical Trials LLC, Uniontown, PA 15401

• Patricia D. Salvato, MD · Diversified Medical Practices, P.A., Houston, TX 77057

• Lawrence P. Schwartz, MD · HCCA Clinical Research Solutions, New York, NY 10016

• Michael C. Hagan, MD · Montana Health Research Institute Inc., Billings, MT 59102

• Martin J. Schear, MD · Dayton Clinical Research, Dayton, OH 45406

• Stephen Ong, MD · MD Medical Research, Oxon Hill, MD 20745

• April Palmer, MD · Clinical Trials Of America Inc., Shreveport, LA 71105

• Derek D. Muse, MD · Highland Clinical Research, Salt Lake City, UT 84124

• Jose M. Carpio, MD · The Community Research of South Florida, Hialeah, FL 33016

• Thomas M Birch, MD · Holy Name Medical Center, Teaneck, NJ 07666

• Barry K McLean, MD · Cahaba Research, Birmingham, AL 35242

• Barry N Heller, MD · Novo Research Inc., Highland Heights, KY 41076

• Karl V Sitz, MD · Little Rock Allergy & Asthma Clinical Research Center, Little Rock, AR 72205

• Thomas C Nilsson, MD · Midwest Allergy and Asthma Clinic, P.C., Omaha, NE 68130

• Douglas W Mapel, MD · Clinical Trial Connection, Flagstaff, AZ 86001

• Ronald G DeGarmo, DO · DeGarmo Institute of Medical Research, Greer, SC 29651

• Teresa S Sligh, MD · Providence Clinical Research, North Hollywood, CA 91606

• Gary L Sutter, MD · HealthCare Partners Medical Group LLC, Los Angeles, CA 90015

• John P Delgado, MD · Integrated Medical Research, PC, Ashland, Oregon 97520

• Ronald K Stegemoller, MD · American Health Network of IN, LLC, Avon, IN 46123

• Edgar A Marin, MD · Global Clinical Professionals, Miami, FL 33156

• Marie R Albert, DO · Acadia Clinical Research, LLC, Bangor, Maine 04401

• Mark A Turner, MD · Advanced Clinical Research Inc., Meridian, ID 83642

• Terry L Poling, MD · Heartland Research Associates, LLC, Wichita, KS 67207

• David R Hassman, DO · Comprehensive Clinical Research, Berlin, NJ 08009

• William C Simon, DO · Professional Research Network of Kansas, LLC, Wichita, KS 67203

• Brian K Allen, DO · University of Wisconsin La Crosse, La Crosse, WI 54601

• Ernest L Hendrix, MD · North Alabama Research Center LLC, Athens, Alabama 35611

• John A Panuto, MD · HCCA Clinical Research Solutions, Middleburg Heights, OH 44130

• Sadia Dar, MD · HCCA Clinical Research Solutions, Smyrna, TN 37167

• Michael E Hodges, MD · North Central Arkansas Medical Associates, Mountain Home, AZ 72653

• Melanie Hoppers, MD · Physicians Quality Care, Jackson, TN 38305

• Khai S Chang, MD · Lakeview Medical Research, Summerfield, FL 34491

• Arles Perdomo, MD · Best Quality Research, Hialeah, FL 33016

• Neerja Misra, MD · Quick Care Medical, Hamilton, NJ 08690

• Steve Choi, MD · Urgent Care Specialist, LLC DBA Hometown Urgent Care & Occupational Health, Dayton, OH 45432

• Gregory Pokrywka, MD · IRC Clinics, Towson, MD 21204

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2013-02-28

Completion

2013-02-28

Countries

• United States

Study Locations