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Influenza APhase 2NCT02342249

Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects

A Phase 2 study testing VX-787 300 mg, VX-787 600 mg and Oseltamivir 75 mg in people with Influenza A, run by Janssen Research & Development, LLC at 176 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Influenza A
What is being tested?
VX-787 300 mg, VX-787 600 mg and Oseltamivir 75 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
292 participants
Where
176 sitesin 9 countries
Study dates
11 Dec 2014to 25 May 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

176 sites in 9 countries.

176 sites in 9 countries

United States129 sites

  • Study site

    Advance, North Carolina

  • Study site

    Akron, Ohio

  • Study site

    Alexandria, Virginia

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Anderson, Idaho

  • Study site

    Anderson, Indiana

  • Study site

    Arlington, Texas

  • Study site

    Athens, Alabama

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bardstown, Kentucky

  • Study site

    Baytown, Texas

  • Study site

    Belton, Michigan

  • Study site

    Berlin, New Jersey

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida

  • Study site

    Boynton Beach, Florida

  • Study site

    Bradenton, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Brooklyn, New York

  • Study site

    Brooksville, Florida

  • Study site

    Burbank, California

  • Study site

    Canoga Park, California

  • Study site

    Carrollton, Texas

  • Study site

    Chiefland, Florida

  • Study site

    Chula Vista, California

  • Study site

    Clearwater, Florida

  • Study site

    Clinton, Utah

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Georgia

  • Study site

    Coral Gables, Florida

  • Study site

    Corpus Christi, Texas

  • Study site

    Council Bluffs, Iowa

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Doral, Florida

  • Study site

    East Providence, Rhode Island

  • Study site

    Edgewater, Florida

  • Study site

    El Cajon, California

  • Study site

    Encino, California

  • Study site

    Eunice, Louisiana

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Fremont, Nebraska

  • Study site

    Fresno, California

  • Study site

    Garden Grove, California

  • Study site

    Greer, South Carolina

  • Study site

    Gulf Shores, Alabama

  • Study site

    Harbor City, California

  • Study site

    Harleysville, Pennsylvania

  • Study site

    Harrisburg, Arkansas

  • Study site

    Hazard, Kentucky

  • Study site

    Hialeah, Florida

  • Study site

    Hickory, North Carolina

  • Study site

    Hilliard, Ohio

  • Study site

    Homestead, Florida

  • Study site

    Houston, Texas

  • Study site

    Huber Heights, Ohio

  • Study site

    Humble, Texas

  • Study site

    Huntington Beach, California

  • Study site

    Huntsville, Alabama

  • Study site

    Idaho Falls, Idaho

  • Study site

    Jacksonville, Florida

  • Study site

    Jenkintown, Pennsylvania

  • Study site

    Johnston, Rhode Island

  • Study site

    Katy, Texas

  • Study site

    Kissimmee, Florida

  • Study site

    La Crosse, Wisconsin

  • Study site

    La Mesa, California

  • Study site

    Lake Worth, Florida

  • Study site

    Lakeland, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Laurens, South Carolina

  • Study site

    Lomita, California

  • Study site

    Long Beach, California

  • Study site

    Long Beach Resort, Florida

  • Study site

    Mandeville, Louisiana

  • Study site

    Meridian, Idaho

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Morehead City, North Carolina

  • Study site

    Morganton, North Carolina

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Muncie, Indiana

  • Study site

    New Port Richey, Florida

  • Study site

    New York, New York

  • Study site

    Newburgh, Indiana

  • Study site

    Niles, Michigan

  • Study site

    North Miami Beach, Florida

  • Study site

    Northglenn, Colorado

  • Study site

    Norwalk, California

  • Study site

    Oakland, California

  • Study site

    Oceanside, California

  • Study site

    Orlando, Florida

  • Study site

    Ormond Beach, Florida

  • Study site

    Overland Park, Kansas

  • Study site

    Oxon Hill, Maryland

  • Study site

    Paramount, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arkansas

  • Study site

    Plano, Texas

  • Study site

    Rapid City, South Dakota

  • Study site

    Rochester, New York

  • Study site

    Rock Hill, South Carolina

  • Study site

    Rosedale, New York

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Monica, California

  • Study site

    Sarasota, Florida

  • Study site

    Scottsboro, Alabama

  • Study site

    Shreveport, Louisiana

  • Study site

    Simpsonville, South Carolina

  • Study site

    South Jordan, Utah

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Tampa, Florida

  • Study site

    Tomball, Texas

  • Study site

    Troy, Michigan

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tustin, California

  • Study site

    Upland, California

  • Study site

    Warminster, Pennsylvania

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Palm Beach, Florida

  • Study site

    Worcester, Massachusetts

Other trials in United States

South Africa13 sites

  • Study site

    Boksburg

  • Study site

    Breyten

  • Study site

    Cape Town

  • Study site

    Durban

  • Study site

    Johannesburg

  • Study site

    Kempton Park

  • Study site

    Krugersdorp

  • Study site

    Middelburg

  • Study site

    Moloto South

  • Study site

    Pretoria

  • Study site

    Thabazimbi

  • Study site

    Vanderbijlpark

  • Study site

    Worcester

Other trials in South Africa

Canada10 sites

  • Study site

    Brampton, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Mirabel, Quebec

  • Study site

    Montreal, Quebec

  • Study site

    Mount Pearl, Newfoundland and Labrador

  • Study site

    Newmarket, Ontario

  • Study site

    Saint-Jérôme, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Trois-Rivières, Quebec

  • Study site

    West Vancouver, British Columbia

Other trials in Canada

Latvia7 sites

  • Study site

    Balvi

  • Study site

    Daugavpils

  • Study site

    Jēkabpils

  • Study site

    Jelgava

  • Study site

    Kuldīga

  • Study site

    Lielvārde

  • Study site

    Riga

Other trials in Latvia

Estonia5 sites

  • Study site

    Paide

  • Study site

    Saku

  • Study site

    Tallinn

  • Study site

    Tartu

  • Study site

    Võru

Other trials in Estonia

Germany5 sites

  • Study site

    Berlin

  • Study site

    Essen

  • Study site

    Goch

  • Study site

    Hamburg

  • Study site

    Stuhr

Other trials in Germany

Belgium4 sites

  • Study site

    Borgerhout

  • Study site

    Linkebeek

  • Study site

    Massemen

  • Study site

    Wichelen

Other trials in Belgium

Bulgaria2 sites

  • Study site

    Sofia

  • Study site

    Veliko Tarnovo

Other trials in Bulgaria

Puerto Rico1 site

  • Study site

    Toa Baja

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Influenza A
Being tested
VX-787 300 mg, VX-787 600 mg, Oseltamivir 75 mg, Placebo
Keywords
Influenza A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VX-787 300 mgDrug

    Also called JNJ-63623872

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

  • VX-787 600 mgDrug

    Also called JNJ-63623872

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

  • Oseltamivir 75 mgDrug

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

  • PlaceboDrug

    Subjects will receive matching placebo of Oseltamivir

Study groups in NCT02342249
Study groupRoleWhat they receive
VX-787 Placebo BID + Oseltamivir Placebo BIDPlacebo comparatorSubjects 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.
Receives: Drug: Placebo
VX-787 300 mg BID + Oseltamivir Placebo BIDActive comparatorSubjects 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.
Receives: Drug: VX-787 300 mg; Drug: Placebo
VX-787 600 mg BID + Oseltamivir Placebo BIDActive comparatorSubjects 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.
Receives: Drug: VX-787 600 mg; Drug: Placebo
VX-787 600 mg BID + Oseltamivir 75 mg BIDActive comparatorSubjects 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.
Receives: Drug: VX-787 600 mg; Drug: Oseltamivir 75 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Day 8

Secondary outcomes (6)

  1. Time to Resolution of Influenza Symptoms After Initiation of Study Drug

    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.

    Measured: Baseline up to Day 14

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

    Measured: Day 14

  3. Antiviral effect and viral kinetics composite

    Antiviral effect and viral kinetics in relation to:

    • Duration of viral shedding in nasal secretions by qRT-PCR and viral culture
    • AUC of the log10 viral load measured by viral culture
    • Peak viral shedding titer by qRT-PCR and viral culture.

    Measured: Days 1 - 8

  4. Clinical composite symptom scores

    Clinical symptom scores

    • Composite symptom score AUC
    • Time to peak of composite symptom score,
    • Duration and time to resolution of composite symptom score from peak

    Measured: Day 14

  5. Pharmacokinetic parameters of VX787, as determined by population analysis

    A population Pharmacokinetic Pharmacodynamic analysis of plasma concentration data of VX-787 will be performed using the nonlinear mixed effects modeling approach.

    Measured: Day 14

  6. Viral sequence analysis to monitor for emergence of viral variants resistant to VX 787 and to oseltamivir

    Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2015 (estimated)
  2. Study start11 Dec 2014
  3. Primary completion25 May 2016
  4. Study completion25 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02342249
Sponsor's protocol ID
CR107745
Other IDs
VX-787FLZ2001, VX14-787-103, 2014-004068-39, 2014
Status last verified
Jan 2025
First submitted
7 Jan 2015
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 30428049

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VX-787 300 mg, VX-787 600 mg and Oseltamivir 75 mg in people with Influenza A, run by Janssen Research & Development, LLC at 176 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, South Africa, Canada, Latvia, Estonia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve (AUC) of the log10 Nasal Viral Load on Day 8 (time frame: Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02342249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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