Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects

January 31, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
292

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Borgerhout, Belgium
      • Linkebeek, Belgium
      • Massemen, Belgium
      • Wichelen, Belgium
  • Bulgaria
      • Sofia, Bulgaria
      • Veliko Turnovo, Bulgaria
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • West Vancouver, British Columbia, Canada
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
    • Ontario
      • Brampton, Ontario, Canada
      • NewMarket, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Mirabel, Quebec, Canada
      • Montreal, Quebec, Canada
      • Saint-Jerome, Quebec, Canada
      • Trois-Rivières, Quebec, Canada
  • Estonia
      • Paide, Estonia
      • Saku, Estonia
      • Tallinn, Estonia
      • Tartu, Estonia
      • Voru, Estonia
  • Germany
      • Berlin, Germany
      • Essen, Germany
      • Goch, Germany
      • Hamburg, Germany
      • Stuhr, Germany
  • Latvia
      • Balvi, Latvia
      • Daugavpils, Latvia
      • Jekabpils, Latvia
      • Jelgava, Latvia
      • Kuldiga, Latvia
      • Lielvarde, Latvia
      • Riga, Latvia
  • Puerto Rico
      • Toa Baja, Puerto Rico
  • South Africa
      • 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 Africa
      • Pretoria, South Africa
      • Thabazimbi, South Africa
      • Van Der Bijl Park, South Africa
      • Worcester, South Africa
  • United States
    • Alabama
      • Athens, Alabama, United States
      • Birmingham, Alabama, United States
      • Gulf Shores, Alabama, United States
      • Huntsville, Alabama, United States
      • Scottsboro, Alabama, United States
    • Arkansas
      • Harrisburg, Arkansas, United States
      • Phoenix, Arkansas, United States
    • California
      • 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
      • Colorado Springs, Colorado, United States
      • Northglenn, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • 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, 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
      • Saint Petersburg, Florida, United States
      • Sarasota, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Columbus, Georgia, United States
    • Idaho
      • Anderson, Idaho, United States
      • Idaho Falls, Idaho, United States
      • Meridian, Idaho, United States
    • Indiana
      • Anderson, Indiana, United States
      • Muncie, Indiana, United States
      • Newburgh, Indiana, United States
    • Iowa
      • Council Bluffs, Iowa, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Kentucky
      • Bardstown, Kentucky, United States
      • Hazard, Kentucky, United States
    • Louisiana
      • Eunice, Louisiana, United States
      • Mandeville, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Oxon Hill, Maryland, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • Belton, Michigan, United States
      • Niles, Michigan, United States
      • Troy, Michigan, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Nebraska
      • Fremont, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Berlin, New Jersey, United States
    • New York
      • Brooklyn, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
      • Rosedale, New York, United States
    • North Carolina
      • 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
    • Ohio
      • Akron, Ohio, United States
      • Dayton, Ohio, United States
      • Hilliard, Ohio, United States
      • Huber Heights, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Pennsylvania
      • Harleysville, Pennsylvania, United States
      • Jenkintown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Warminster, Pennsylvania, United States
    • Rhode Island
      • East Providence, Rhode Island, United States
      • Johnston, Rhode Island, United States
    • South Carolina
      • Greer, South Carolina, United States
      • Laurens, South Carolina, United States
      • Mount Pleasant, South Carolina, United States
      • Rock Hill, South Carolina, United States
      • Simpsonville, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Bristol, Tennessee, United States
    • Texas
      • 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
    • Utah
      • Clinton, Utah, United States
      • Salt Lake City, Utah, United States
      • South Jordan, Utah, United States
    • Virginia
      • Alexandria, Virginia, United States
    • Wisconsin
      • La Crosse, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Part A

  1. Willing and able to comply with the NP swab procedure
  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: Part B

  1. 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.
  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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Placebo
Subjects will receive matching placebo of Oseltamivir
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.
Drug: Placebo
Subjects will receive matching placebo of Oseltamivir
Drug: VX-787 300 mg
A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.
Other Names:
  • JNJ-63623872
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.
Drug: Placebo
Subjects will receive matching placebo of Oseltamivir
Drug: 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.
Other Names:
  • JNJ-63623872
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.
Drug: 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.
Other Names:
  • JNJ-63623872
Drug: Oseltamivir 75 mg
A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area under the curve (AUC) of the log10 Nasal Viral Load on Day 8
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Resolution of Influenza Symptoms After Initiation of Study Drug
Time Frame: Baseline up to Day 14
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.
Baseline up to Day 14
Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs
Time Frame: Day 14
Day 14
Antiviral effect and viral kinetics composite
Time Frame: Days 1 - 8

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.
Days 1 - 8
Clinical composite symptom scores
Time Frame: Day 14

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
Day 14
Pharmacokinetic parameters of VX787, as determined by population analysis
Time Frame: Day 14
A population Pharmacokinetic Pharmacodynamic analysis of plasma concentration data of VX-787 will be performed using the nonlinear mixed effects modeling approach.
Day 14
Viral sequence analysis to monitor for emergence of viral variants resistant to VX 787 and to oseltamivir
Time Frame: Day 14
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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