Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
NCT ID: NCT02342249
Last Updated: 2025-02-04
Study Results
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Basic Information
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COMPLETED
PHASE2
292 participants
INTERVENTIONAL
2014-12-11
2016-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VX-787 Placebo BID + Oseltamivir Placebo BID
Subjects will receive 10 doses of matching placebo of VX-787 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.
Placebo
Subjects will receive matching placebo of Oseltamivir
VX-787 300 mg BID + Oseltamivir Placebo BID
Subjects will receive 10 doses of VX-787 300 milligram (mg) tablet along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.
VX-787 300 mg
A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.
Placebo
Subjects will receive matching placebo of Oseltamivir
VX-787 600 mg BID + Oseltamivir Placebo BID
Subjects will receive 10 doses of VX-787 600 mg (2\*300 mg tablets) along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.
VX-787 600 mg
A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days.
Placebo
Subjects will receive matching placebo of Oseltamivir
VX-787 600 mg BID + Oseltamivir 75 mg BID
Subjects will receive 10 doses of VX-787 600 mg tablets (2\*300 mg tablets) along with 75 mg Oseltamivir capsule twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.
VX-787 600 mg
A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days.
Oseltamivir 75 mg
A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.
Interventions
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VX-787 300 mg
A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.
VX-787 600 mg
A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days.
Oseltamivir 75 mg
A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.
Placebo
Subjects will receive matching placebo of Oseltamivir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject will sign and date an informed consent form (ICF)
3. Presenting to the clinic with symptoms suggestive of a diagnosis of acute influenza. Symptoms include oral temperature ≥38°C (100.4°F) within the prior 24 hours, at least 1 respiratory symptom AND at least 1 systemic symptom.
4. Understand that no study treatment will be provided to subjects in Part A but that they are free to receive any treatment considered appropriate by their physician
Part B
1. Willing and able to comply with study requirements including treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures
2. Subject will sign and date an ICF
3. Present to the clinic with symptoms suggestive of a diagnosis of acute influenza. Symptoms include documented oral temperature ≥38°C (100.4°F) any time during the screening process, at least 1 respiratory symptom AND at least 1 systemic symptom, both scored as at least "moderate".
4. The time of onset of flu-like symptoms to the time anticipated for the start of treatment must be ≤48 hours. Onset of symptoms is defined as the first time (within 1 hour) the subject becomes aware of respiratory or systemic symptoms compatible with the flu or experiences an oral temperature ≥38°C (100.4°F)
5. Positive Rapid Influenza Diagnostic Test for influenza type A
6. Body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive, and a total body weight \>50 kg
Exclusion Criteria
2. Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal tract surgery, except appendectomy).
3. Immunized (intranasal or injected vaccine) against influenza in the 6 months before study entry.
4. At Screening, an ECG that is abnormal and deemed by the investigator(s) to be clinically significant.
5. For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol.
6. For male subjects, unwilling to comply with contraception requirements as outlined in the study protocol.
7. Blood donation (of approximately 1 pint \[500 mL\] or more) within 56 days before the first study drug dose.
8. Use of the following medications:
* Influenza antiviral medication (oseltamivir, zanamivir, rimantidine, or amantadine) within 14 days or ribavirin within 6 months of screening.
* Substrates of OATP1B1 and/or OATP1B3, including atrasentan, bosentan, ezetimibe, glyburide, irinotecan, repaglinide, rifampin, telmisartan, valsartan, and olmesartan, from Day 1 through the last dose of study drug. "Statins" (i.e., HMG CoA reductase inhibitors) may be continued, but subjects should be cautioned and observed for potential "statin"-related toxicity. Alternatively, subjects can abstain from statins for the duration of study drug dosing.
* Strong inhibitors or inducers of CYP3A metabolism, including carbamazepine, clarithromycin, HIV and HCV protease inhibitors, itraconazole, ketoconazole, nefazodone, phenytoin, posaconazole, rifampin, St. John's wort, telithromycin, and voriconazole from 2 weeks prior to the first dose of study drug until the last PK sample is collected on Day 8.
* An investigational drug or device 30 days before the first dose of study drug, 5 half lives before the first dose of study drug, or time determined by local requirements, whichever is longest.
9. History of excessive alcohol consumption.
10. History of known or current usage of drugs of abuse.
11. Hospitalized subjects and subjects with bacterial infections requiring systemic antibacterial agents at the time of screening.
18 Years
64 Years
ALL
No
Sponsors
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Janssen Pharmaceuticals
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Athens, Alabama, United States
Birmingham, Alabama, United States
Gulf Shores, Alabama, United States
Huntsville, Alabama, United States
Scottsboro, Alabama, United States
Harrisburg, Arkansas, United States
Phoenix, Arkansas, United States
Anaheim, California, United States
Burbank, California, United States
Canoga Park, California, United States
Chula Vista, California, United States
El Cajon, California, United States
Encino, California, United States
Fresno, California, United States
Garden Grove, California, United States
Harbor City, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
Lomita, California, United States
Long Beach, California, United States
Norwalk, California, United States
Oakland, California, United States
Oceanside, California, United States
Paramount, California, United States
San Diego, California, United States
Santa Monica, California, United States
Tustin, California, United States
Upland, California, United States
Colorado Springs, Colorado, United States
Northglenn, Colorado, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Boynton Beach, Florida, United States
Bradenton, Florida, United States
Brooksville, Florida, United States
Chiefland, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Doral, Florida, United States
Edgewater, Florida, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Lake Worth, Florida, United States
Lakeland, Florida, United States
Long Beach Resort, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
North Miami Beach, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Anderson, Idaho, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Anderson, Indiana, United States
Muncie, Indiana, United States
Newburgh, Indiana, United States
Council Bluffs, Iowa, United States
Overland Park, Kansas, United States
Bardstown, Kentucky, United States
Hazard, Kentucky, United States
Eunice, Louisiana, United States
Mandeville, Louisiana, United States
Shreveport, Louisiana, United States
Oxon Hill, Maryland, United States
Worcester, Massachusetts, United States
Belton, Michigan, United States
Niles, Michigan, United States
Troy, Michigan, United States
St Louis, Missouri, United States
Fremont, Nebraska, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Brooklyn, New York, United States
New York, New York, United States
Rochester, New York, United States
Rosedale, New York, United States
Advance, North Carolina, United States
Hickory, North Carolina, United States
Morehead City, North Carolina, United States
Morganton, North Carolina, United States
Salisbury, North Carolina, United States
Akron, Ohio, United States
Dayton, Ohio, United States
Hilliard, Ohio, United States
Huber Heights, Ohio, United States
Tulsa, Oklahoma, United States
Harleysville, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Warminster, Pennsylvania, United States
East Providence, Rhode Island, United States
Johnston, Rhode Island, United States
Greer, South Carolina, United States
Laurens, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Rock Hill, South Carolina, United States
Simpsonville, South Carolina, United States
Rapid City, South Dakota, United States
Bristol, Tennessee, United States
Amarillo, Texas, United States
Arlington, Texas, United States
Austin, Texas, United States
Baytown, Texas, United States
Carrollton, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
Katy, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Clinton, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
Alexandria, Virginia, United States
La Crosse, Wisconsin, United States
Milwaukee, Wisconsin, United States
Borgerhout, , Belgium
Linkebeek, , Belgium
Massemen, , Belgium
Wichelen, , Belgium
Sofia, , Bulgaria
Veliko Tarnovo, , Bulgaria
Calgary, Alberta, Canada
West Vancouver, British Columbia, Canada
Mount Pearl, Newfoundland and Labrador, Canada
Brampton, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Mirabel, Quebec, Canada
Montreal, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Trois-Rivières, Quebec, Canada
Paide, , Estonia
Saku, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Võru, , Estonia
Berlin, , Germany
Essen, , Germany
Goch, , Germany
Hamburg, , Germany
Stuhr, , Germany
Balvi, , Latvia
Daugavpils, , Latvia
Jelgava, , Latvia
Jēkabpils, , Latvia
Kuldīga, , Latvia
Lielvārde, , Latvia
Riga, , Latvia
Toa Baja, , Puerto Rico
Boksburg, , South Africa
Breyten, , South Africa
Cape Town, , South Africa
Durban, , South Africa
Johannesburg, , South Africa
Kempton Park, , South Africa
Krugersdorp, , South Africa
Middelburg, , South Africa
Moloto South, , South Africa
Pretoria, , South Africa
Thabazimbi, , South Africa
Vanderbijlpark, , South Africa
Worcester, , South Africa
Countries
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References
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Finberg RW, Lanno R, Anderson D, Fleischhackl R, van Duijnhoven W, Kauffman RS, Kosoglou T, Vingerhoets J, Leopold L. Phase 2b Study of Pimodivir (JNJ-63623872) as Monotherapy or in Combination With Oseltamivir for Treatment of Acute Uncomplicated Seasonal Influenza A: TOPAZ Trial. J Infect Dis. 2019 Mar 15;219(7):1026-1034. doi: 10.1093/infdis/jiy547.
Other Identifiers
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CR107745
Identifier Type: -
Identifier Source: org_study_id
VX-787FLZ2001
Identifier Type: OTHER
Identifier Source: secondary_id
VX14-787-103
Identifier Type: OTHER
Identifier Source: secondary_id
2014-004068-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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