- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02342249
Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
June 9, 2017 updated by: Janssen Research & Development, LLC
A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study of 2 Dose Levels of VX 787 Administered as Monotherapy and One Dose Level of VX-787 Administered in Combination With Oseltamivir for the Treatment of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
292
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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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 Turnovo, Bulgaria
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Mount Pearl, Canada
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Alberta
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Calgary, Alberta, Canada
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British Columbia
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West Vancouver, British Columbia, Canada
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Ontario
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Brampton, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Mirabel, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Jerome, 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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Voru, 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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Jekabpils, Latvia
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Jelgava, Latvia
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Kuldiga, Latvia
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Lielvarde, Latvia
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Riga, Latvia
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Toa Baja, Puerto Rico
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Alabama
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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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Arkansas
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Harrisburg, Arkansas, United States
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Phoenix, Arkansas, United States
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California
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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
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Colorado Springs, Colorado, United States
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Northglenn, Colorado, United States
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District of Columbia
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Washington, D.C., District of Columbia, United States
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Florida
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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, 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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Saint Petersburg, Florida, United States
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Sarasota, 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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Georgia
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Idaho
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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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Indiana
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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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Iowa
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Council Bluffs, Iowa, United States
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Kansas
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Overland Park, Kansas, United States
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Kentucky
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Bardstown, Kentucky, United States
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Hazard, Kentucky, United States
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Louisiana
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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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Maryland
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Oxon Hill, Maryland, United States
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Massachusetts
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Worcester, Massachusetts, United States
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Michigan
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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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Missouri
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Saint Louis, Missouri, United States
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Nebraska
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Fremont, Nebraska, United States
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Nevada
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Las Vegas, Nevada, United States
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New Jersey
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Berlin, New Jersey, United States
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New York
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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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North Carolina
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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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Ohio
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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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Oklahoma
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Tulsa, Oklahoma, United States
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Pennsylvania
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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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Rhode Island
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East Providence, Rhode Island, United States
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Johnston, Rhode Island, United States
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South Carolina
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Greer, South Carolina, United States
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Laurens, South Carolina, United States
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Mount 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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South Dakota
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Rapid City, South Dakota, United States
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Tennessee
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Bristol, Tennessee, United States
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Texas
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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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Utah
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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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Virginia
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Alexandria, Virginia, United States
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Wisconsin
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La Crosse, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: Part A
- 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
Exclusion Criteria: Part B
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 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.
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Subjects will receive matching placebo of Oseltamivir
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Active Comparator: 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.
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Subjects will receive matching placebo of Oseltamivir
A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.
Other Names:
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Active Comparator: 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.
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Subjects will receive matching placebo of Oseltamivir
A oral dose of VX-787 600 mg (formulated as 2*300 mg tablets) will be administered over 5-6 days.
Other Names:
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Active Comparator: 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.
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A oral dose of VX-787 600 mg (formulated as 2*300 mg tablets) will be administered over 5-6 days.
Other Names:
A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Area under the curve (AUC) of the log10 Nasal Viral Load on Day 8
Time Frame: Day 8
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Area under the curve (AUC) of the log10 nasal viral load is measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).
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Day 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Resolution of Influenza Symptoms After Initiation of Study Drug
Time Frame: Baseline up to Day 14
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Estimated acceleration factors expressed as the ratio of the time to resolution of influenza symptoms as compared to placebo time to negativity.
Resolution of influenza symptoms was the time of the first of 3 evaluations (over 24 hours) in which all symptom scores for each of the 3 assessments are 0 or 1 for all 7 primary influenza symptoms (cough, sore throat, headache, nasal stuffiness, feverishness or chills, muscle or joint pain, and fatigue) of the Flu-iiQ^TM.
The Flu-iiQ^TM questionnaire consists of 4 modules, including 1 module assessing influenza symptoms, 1 module assessing the impact of influenza on normal functioning, and 2 modules assessing the impact of influenza on the subject's emotional state.
The Influenza Symptom assessment (Module 1) is scored on a 4 point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) for each of 10 influenza symptoms.
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Baseline up to Day 14
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Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs
Time Frame: Day 14
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Day 14
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Antiviral effect and viral kinetics composite
Time Frame: Days 1 - 8
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Antiviral effect and viral kinetics in relation to:
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Days 1 - 8
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Clinical composite symptom scores
Time Frame: Day 14
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Clinical symptom scores
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Day 14
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Pharmacokinetic parameters of VX787, as determined by population analysis
Time Frame: Day 14
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A population Pharmacokinetic Pharmacodynamic analysis of plasma concentration data of VX-787 will be performed using the nonlinear mixed effects modeling approach.
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Day 14
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Viral sequence analysis to monitor for emergence of viral variants resistant to VX 787 and to oseltamivir
Time Frame: Day 14
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Day 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 11, 2014
Primary Completion (Actual)
May 25, 2016
Study Completion (Actual)
May 25, 2016
Study Registration Dates
First Submitted
January 7, 2015
First Submitted That Met QC Criteria
January 16, 2015
First Posted (Estimate)
January 19, 2015
Study Record Updates
Last Update Posted (Actual)
June 14, 2017
Last Update Submitted That Met QC Criteria
June 9, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR107745
- VX-787FLZ2001 (Other Identifier: Janssen Research & Development, LLC)
- VX14-787-103 (Other Identifier: Janssen Research & Development, LLC)
- 2014-004068-39 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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