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Completed

NCT Number: NCT01561807

A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza Virus

The purpose of this study is to determine the antiviral activity and safety of VX-787 given to healthy adult volunteers that have been inoculated with the influenza virus.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Negative human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C(HCV) antibody screen
  • Have not been vaccinated for influenza virus since 2006 or had a known influenza-like illness in the current season (as determined in the medical history), defined as in the last 12 months before Screening

Exclusion criteria

  • Subjects who are pregnant or nursing, or who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period (from at least 14 days before the first dose until 90 days of the last dose of study drug)
  • Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness
  • Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
  • Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral inoculation
  • Intending to travel(to countries for which vaccinations are recommended or where high risk of infections exists)
  • Subjects with a history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any etiology; any history during adulthood of asthma of any etiology, COPD, or any use of a bronchodilator or other asthma medication during adulthood
  • Regular daily smokers
  • History or evidence of autoimmune disease or known impaired immune responsiveness
  • History of heart failure or any other severe cardiac abnormality including clinically significant arrhythmia
  • Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine, medication, or experimental respiratory viral challenge delivered directly to the respiratory tract within 1 year before viral inoculation
  • Previous exposure to study drug or similar substance(s)

Treatment and study plan

VX-787

Drug

Placebo

Drug

Primary outcomes

  1. The primary endpoint is viral AUC as calculated in cell culture of nasal swabs (quantitation of nasal swabs for viral infectivity by cell culture), from initiation of VX-787 treatment

    Time frame: up to 11 days

Secondary outcomes

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

    Time frame: up to 33 days

  2. Total tissue count and total mucus weight after viral inoculation

    Time frame: up to 10 days

  3. Sequence analysis of the relevant target region of influenza

    Time frame: up to 8 days

  4. Pharmacokinetic (PK) parameters of VX-787

    Time frame: 8 days

    As measured by AUC, Cmax, tmax

  5. Composite symptom score AUC

    Time frame: up to 8 days

  6. Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment

    Time frame: up to 8 days

  7. Duration of viral shedding by cell culture and/or RT-PCR

    Time frame: up to 8 days

  8. Peak viral shedding titer by cell culture and/or RT-PCR

    Time frame: up to 8 days

  9. Time to resolution from peak viral shedding by cell culture and/or RT-PCR

    Time frame: up to 8 days

  10. Time to peak of composite sympton score, duration, and time to resolution of composite score from peak

    Time frame: up to 8 days

  11. Peak severity of symptoms after viral inoculation

    Time frame: up to 8 days

  12. Duration of influenza-like illness after viral inoculation

    Time frame: up to 8 days

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 2a, Randomized, Double-Blind,Placebo-Controlled Study to Investigate the Effects of VX-787 Administered to Adult Volunteers Experimentally Inoculated With Live Influenza Virus

Important dates

Study start
2012
Primary completion
2012
First posted
Mar 23, 2012
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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