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Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects

9. juni 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

292

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Borgerhout, Belgia
      • Linkebeek, Belgia
      • Massemen, Belgia
      • Wichelen, Belgia
  • Bulgaria
      • Sofia, Bulgaria
      • Veliko Turnovo, Bulgaria
  • Canada
      • Mount Pearl, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • West Vancouver, British Columbia, Canada
    • Ontario
      • Brampton, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Mirabel, Quebec, Canada
      • Montreal, Quebec, Canada
      • Saint-Jerome, Quebec, Canada
      • Trois-Rivières, Quebec, Canada
  • Estland
      • Paide, Estland
      • Saku, Estland
      • Tallinn, Estland
      • Tartu, Estland
      • Voru, Estland
  • Forente stater
    • Alabama
      • Athens, Alabama, Forente stater
      • Birmingham, Alabama, Forente stater
      • Gulf Shores, Alabama, Forente stater
      • Huntsville, Alabama, Forente stater
      • Scottsboro, Alabama, Forente stater
    • Arkansas
      • Harrisburg, Arkansas, Forente stater
      • Phoenix, Arkansas, Forente stater
    • California
      • Anaheim, California, Forente stater
      • Burbank, California, Forente stater
      • Canoga Park, California, Forente stater
      • Chula Vista, California, Forente stater
      • El Cajon, California, Forente stater
      • Encino, California, Forente stater
      • Fresno, California, Forente stater
      • Garden Grove, California, Forente stater
      • Harbor City, California, Forente stater
      • Huntington Beach, California, Forente stater
      • La Mesa, California, Forente stater
      • Lomita, California, Forente stater
      • Long Beach, California, Forente stater
      • Norwalk, California, Forente stater
      • Oakland, California, Forente stater
      • Oceanside, California, Forente stater
      • Paramount, California, Forente stater
      • San Diego, California, Forente stater
      • Santa Monica, California, Forente stater
      • Tustin, California, Forente stater
      • Upland, California, Forente stater
    • Colorado
      • Colorado Springs, Colorado, Forente stater
      • Northglenn, Colorado, Forente stater
    • District of Columbia
      • Washington, D.C., District of Columbia, Forente stater
    • Florida
      • Boca Raton, Florida, Forente stater
      • Boynton Beach, Florida, Forente stater
      • Bradenton, Florida, Forente stater
      • Brooksville, Florida, Forente stater
      • Chiefland, Florida, Forente stater
      • Clearwater, Florida, Forente stater
      • Coral Gables, Florida, Forente stater
      • Doral, Florida, Forente stater
      • Edgewater, Florida, Forente stater
      • Fort Myers, Florida, Forente stater
      • Hialeah, Florida, Forente stater
      • Homestead, Florida, Forente stater
      • Jacksonville, Florida, Forente stater
      • Kissimmee, Florida, Forente stater
      • Lake Worth, Florida, Forente stater
      • Lakeland, Florida, Forente stater
      • Long Beach, Florida, Forente stater
      • Miami, Florida, Forente stater
      • New Port Richey, Florida, Forente stater
      • North Miami Beach, Florida, Forente stater
      • Orlando, Florida, Forente stater
      • Ormond Beach, Florida, Forente stater
      • Pembroke Pines, Florida, Forente stater
      • Saint Petersburg, Florida, Forente stater
      • Sarasota, Florida, Forente stater
      • Tampa, Florida, Forente stater
      • West Palm Beach, Florida, Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater
      • Columbus, Georgia, Forente stater
    • Idaho
      • Anderson, Idaho, Forente stater
      • Idaho Falls, Idaho, Forente stater
      • Meridian, Idaho, Forente stater
    • Indiana
      • Anderson, Indiana, Forente stater
      • Muncie, Indiana, Forente stater
      • Newburgh, Indiana, Forente stater
    • Iowa
      • Council Bluffs, Iowa, Forente stater
    • Kansas
      • Overland Park, Kansas, Forente stater
    • Kentucky
      • Bardstown, Kentucky, Forente stater
      • Hazard, Kentucky, Forente stater
    • Louisiana
      • Eunice, Louisiana, Forente stater
      • Mandeville, Louisiana, Forente stater
      • Shreveport, Louisiana, Forente stater
    • Maryland
      • Oxon Hill, Maryland, Forente stater
    • Massachusetts
      • Worcester, Massachusetts, Forente stater
    • Michigan
      • Belton, Michigan, Forente stater
      • Niles, Michigan, Forente stater
      • Troy, Michigan, Forente stater
    • Missouri
      • Saint Louis, Missouri, Forente stater
    • Nebraska
      • Fremont, Nebraska, Forente stater
    • Nevada
      • Las Vegas, Nevada, Forente stater
    • New Jersey
      • Berlin, New Jersey, Forente stater
    • New York
      • Brooklyn, New York, Forente stater
      • New York, New York, Forente stater
      • Rochester, New York, Forente stater
      • Rosedale, New York, Forente stater
    • North Carolina
      • Advance, North Carolina, Forente stater
      • Hickory, North Carolina, Forente stater
      • Morehead City, North Carolina, Forente stater
      • Morganton, North Carolina, Forente stater
      • Salisbury, North Carolina, Forente stater
    • Ohio
      • Akron, Ohio, Forente stater
      • Dayton, Ohio, Forente stater
      • Hilliard, Ohio, Forente stater
      • Huber Heights, Ohio, Forente stater
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater
    • Pennsylvania
      • Harleysville, Pennsylvania, Forente stater
      • Jenkintown, Pennsylvania, Forente stater
      • Philadelphia, Pennsylvania, Forente stater
      • Warminster, Pennsylvania, Forente stater
    • Rhode Island
      • East Providence, Rhode Island, Forente stater
      • Johnston, Rhode Island, Forente stater
    • South Carolina
      • Greer, South Carolina, Forente stater
      • Laurens, South Carolina, Forente stater
      • Mount Pleasant, South Carolina, Forente stater
      • Rock Hill, South Carolina, Forente stater
      • Simpsonville, South Carolina, Forente stater
    • South Dakota
      • Rapid City, South Dakota, Forente stater
    • Tennessee
      • Bristol, Tennessee, Forente stater
    • Texas
      • Amarillo, Texas, Forente stater
      • Arlington, Texas, Forente stater
      • Austin, Texas, Forente stater
      • Baytown, Texas, Forente stater
      • Carrollton, Texas, Forente stater
      • Corpus Christi, Texas, Forente stater
      • Dallas, Texas, Forente stater
      • Fort Worth, Texas, Forente stater
      • Houston, Texas, Forente stater
      • Humble, Texas, Forente stater
      • Katy, Texas, Forente stater
      • Plano, Texas, Forente stater
      • San Antonio, Texas, Forente stater
      • Tomball, Texas, Forente stater
    • Utah
      • Clinton, Utah, Forente stater
      • Salt Lake City, Utah, Forente stater
      • South Jordan, Utah, Forente stater
    • Virginia
      • Alexandria, Virginia, Forente stater
    • Wisconsin
      • La Crosse, Wisconsin, Forente stater
      • Milwaukee, Wisconsin, Forente stater
  • Latvia
      • Balvi, Latvia
      • Daugavpils, Latvia
      • Jekabpils, Latvia
      • Jelgava, Latvia
      • Kuldiga, Latvia
      • Lielvarde, Latvia
      • Riga, Latvia
  • Puerto Rico
      • Toa Baja, Puerto Rico
  • Tyskland
      • Berlin, Tyskland
      • Essen, Tyskland
      • Goch, Tyskland
      • Hamburg, Tyskland
      • Stuhr, Tyskland

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 64 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: 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.
Legemiddel: Placebo
Subjects will receive matching placebo of Oseltamivir
Aktiv komparator: 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.
Legemiddel: Placebo
Subjects will receive matching placebo of Oseltamivir
Legemiddel: VX-787 300 mg
A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.
Andre navn:
  • JNJ-63623872
Aktiv komparator: 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.
Legemiddel: Placebo
Subjects will receive matching placebo of Oseltamivir
Legemiddel: 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.
Andre navn:
  • JNJ-63623872
Aktiv komparator: 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.
Legemiddel: 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.
Andre navn:
  • JNJ-63623872
Legemiddel: Oseltamivir 75 mg
A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Area under the curve (AUC) of the log10 Nasal Viral Load on Day 8
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Resolution of Influenza Symptoms After Initiation of Study Drug
Tidsramme: 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
Tidsramme: Day 14
Day 14
Antiviral effect and viral kinetics composite
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 14
Day 14

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Samarbeidspartnere

Janssen Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. desember 2014

Primær fullføring (Faktiske)

25. mai 2016

Studiet fullført (Faktiske)

25. mai 2016

Datoer for studieregistrering

Først innsendt

7. januar 2015

Først innsendt som oppfylte QC-kriteriene

16. januar 2015

Først lagt ut (Anslag)

19. januar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR107745
  • VX-787FLZ2001 (Annen identifikator: Janssen Research & Development, LLC)
  • VX14-787-103 (Annen identifikator: Janssen Research & Development, LLC)
  • 2014-004068-39 (EudraCT-nummer)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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