Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects

NCT02342249 | Completed Phase 2 DMC FDA Drug

• 4 other identifiers: CR107745VX-787FLZ2001VX14-787-1032014-004068-39
• Study Type: interventional
• Target: 292
• Locations: 9 countries
• Sites: 176

Brief Summary

The purpose of this study is to evaluate the antiviral effect, as measured by viral titer in nasal secretions in adults with acute uncomplicated seasonal influenza A following administration of VX-787.

Conditions

Influenza A

Keywords

Influenza A

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of the log10 Nasal Viral Load on Day 8

  Area under the curve (AUC) of the log10 nasal viral load is measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).

  Day 8

Secondary Outcomes (6)

• Time to Resolution of Influenza Symptoms After Initiation of Study Drug

  Baseline up to Day 14

• Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs

  Day 14

• Antiviral effect and viral kinetics composite

  Days 1 - 8

• Clinical composite symptom scores

  Day 14

• Pharmacokinetic parameters of VX787, as determined by population analysis

  Day 14

Study Arms (4)

VX-787 Placebo BID + Oseltamivir Placebo BID

PLACEBO COMPARATOR

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.

Drug: Placebo

VX-787 300 mg BID + Oseltamivir Placebo BID

ACTIVE COMPARATOR

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.

Drug: VX-787 300 mg; Drug: Placebo

VX-787 600 mg BID + Oseltamivir Placebo BID

ACTIVE COMPARATOR

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.

Drug: VX-787 600 mg; Drug: Placebo

VX-787 600 mg BID + Oseltamivir 75 mg BID

ACTIVE COMPARATOR

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.

Drug: VX-787 600 mg; Drug: Oseltamivir 75 mg

Interventions

VX-787 300 mg DRUG

A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.

Also known as: JNJ-63623872

VX-787 300 mg BID + Oseltamivir Placebo BID

VX-787 600 mg DRUG

A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days.

Also known as: JNJ-63623872

VX-787 600 mg BID + Oseltamivir 75 mg BID; VX-787 600 mg BID + Oseltamivir Placebo BID

Oseltamivir 75 mg DRUG

A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.

VX-787 600 mg BID + Oseltamivir 75 mg BID

Placebo DRUG

Subjects will receive matching placebo of Oseltamivir

VX-787 300 mg BID + Oseltamivir Placebo BID; VX-787 600 mg BID + Oseltamivir Placebo BID; VX-787 Placebo BID + Oseltamivir Placebo BID

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to comply with the NP swab procedure
• Subject will sign and date an informed consent form (ICF)
• 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.
• 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
• Willing and able to comply with study requirements including treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures
• Subject will sign and date an ICF
• 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".
• 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)
• Positive Rapid Influenza Diagnostic Test for influenza type A
• Body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive, and a total body weight \>50 kg

You may not qualify if:

• History of any illness or any clinical condition that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal tract surgery, except appendectomy).
• Immunized (intranasal or injected vaccine) against influenza in the 6 months before study entry.
• At Screening, an ECG that is abnormal and deemed by the investigator(s) to be clinically significant.
• 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.
• For male subjects, unwilling to comply with contraception requirements as outlined in the study protocol.
• Blood donation (of approximately 1 pint \[500 mL\] or more) within 56 days before the first study drug dose.
• 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.
• History of excessive alcohol consumption.
• History of known or current usage of drugs of abuse.
• Hospitalized subjects and subjects with bacterial infections requiring systemic antibacterial agents at the time of screening.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (176)

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Athens, Alabama, United States

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Birmingham, Alabama, United States

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Gulf Shores, Alabama, United States

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Huntsville, Alabama, United States

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Scottsboro, Alabama, United States

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Harrisburg, Arkansas, United States

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Phoenix, Arkansas, United States

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Anaheim, California, United States

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Burbank, California, United States

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Canoga Park, California, United States

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Chula Vista, California, United States

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El Cajon, California, United States

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Encino, California, United States

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Fresno, California, United States

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Garden Grove, California, United States

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Harbor City, California, United States

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Huntington Beach, California, United States

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La Mesa, California, United States

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Lomita, California, United States

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Long Beach, California, United States

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Norwalk, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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Paramount, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Tustin, California, United States

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Upland, California, United States

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Colorado Springs, Colorado, United States

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Northglenn, Colorado, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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Bradenton, Florida, United States

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Brooksville, Florida, United States

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Chiefland, Florida, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Doral, Florida, United States

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Edgewater, Florida, United States

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Fort Myers, Florida, United States

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Hialeah, Florida, United States

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Homestead, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Lake Worth, Florida, United States

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Lakeland, Florida, United States

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Long Beach Resort, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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North Miami Beach, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Pembroke Pines, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Anderson, Idaho, United States

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Idaho Falls, Idaho, United States

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Meridian, Idaho, United States

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Anderson, Indiana, United States

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Muncie, Indiana, United States

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Newburgh, Indiana, United States

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Council Bluffs, Iowa, United States

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Overland Park, Kansas, United States

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Bardstown, Kentucky, United States

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Hazard, Kentucky, United States

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Eunice, Louisiana, United States

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Mandeville, Louisiana, United States

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Shreveport, Louisiana, United States

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Oxon Hill, Maryland, United States

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Worcester, Massachusetts, United States

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Belton, Michigan, United States

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Niles, Michigan, United States

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Troy, Michigan, United States

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St Louis, Missouri, United States

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Fremont, Nebraska, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Rosedale, New York, United States

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Advance, North Carolina, United States

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Hickory, North Carolina, United States

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Morehead City, North Carolina, United States

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Morganton, North Carolina, United States

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Salisbury, North Carolina, United States

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Akron, Ohio, United States

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Dayton, Ohio, United States

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Hilliard, Ohio, United States

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Huber Heights, Ohio, United States

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Tulsa, Oklahoma, United States

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Harleysville, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Warminster, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Johnston, Rhode Island, United States

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Greer, South Carolina, United States

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Laurens, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Rock Hill, South Carolina, United States

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Simpsonville, South Carolina, United States

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Rapid City, South Dakota, United States

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Bristol, Tennessee, United States

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Amarillo, Texas, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Baytown, Texas, United States

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Carrollton, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Humble, Texas, United States

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Katy, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Tomball, Texas, United States

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Clinton, Utah, United States

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Salt Lake City, Utah, United States

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South Jordan, Utah, United States

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Alexandria, Virginia, United States

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La Crosse, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Borgerhout, Belgium

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Linkebeek, Belgium

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Massemen, Belgium

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Wichelen, Belgium

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Sofia, Bulgaria

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Veliko Tarnovo, Bulgaria

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Calgary, Alberta, Canada

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West Vancouver, British Columbia, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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Brampton, Ontario, Canada

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Newmarket, Ontario, Canada

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Toronto, Ontario, Canada

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Mirabel, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Paide, Estonia

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Saku, Estonia

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Tallinn, Estonia

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Tartu, Estonia

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Võru, Estonia

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Berlin, Germany

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Essen, Germany

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Goch, Germany

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Hamburg, Germany

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Stuhr, Germany

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Balvi, Latvia

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Daugavpils, Latvia

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Jelgava, Latvia

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Jēkabpils, Latvia

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Kuldīga, Latvia

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Lielvārde, Latvia

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Riga, Latvia

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Toa Baja, Puerto Rico

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Boksburg, South Africa

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Breyten, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Johannesburg, South Africa

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Kempton Park, South Africa

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Krugersdorp, South Africa

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Middelburg, South Africa

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Moloto South, South Africa

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Pretoria, South Africa

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Thabazimbi, South Africa

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Vanderbijlpark, South Africa

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Worcester, South Africa

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Related Publications (1)

• 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.

  PMID: 30428049 DERIVED

MeSH Terms

Interventions

pimodivir; Oseltamivir

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 7, 2015
• First Posted: January 19, 2015
• Study Start: December 11, 2014
• Primary Completion: May 25, 2016
• Study Completion: May 25, 2016
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

ES (5); PR (1); ZA (13); LA (7); BU (2); US (129); BE (4); DE (5); CA (10)