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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01561807
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : September 2, 2016
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Virus Drug: VX-787 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2012
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 787 low dose
VX-787 low dose capsule, taken orally for 5 days
Drug: VX-787
Experimental: 787 high dose
VX-787 high dose capsule, taken orally for 5 days
Drug: VX-787
Experimental: Placebo low dose
Matching placebo low dose capsule, taken orally for 5 days
Drug: Placebo
Experimental: Placebo high dose
Matching placebo high dose capsule, taken orally for 5 days
Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01561807

United Kingdom
London, United Kingdom
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Study Director: Jose Trevejo, MD, PhD Vertex Pharmaceuticals Incorporated

Responsible Party: Vertex Pharmaceuticals Incorporated Identifier: NCT01561807     History of Changes
Other Study ID Numbers: VX11-787-101
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases