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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01561807
First received: March 19, 2012
Last updated: January 8, 2014
Last verified: December 2012

March 19, 2012
January 8, 2014
March 2012
October 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01561807 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Total tissue count and total mucus weight after viral inoculation [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • Sequence analysis of the relevant target region of influenza [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) parameters of VX-787 [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    As measured by AUC, Cmax, tmax
  • Composite symptom score AUC [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Duration of viral shedding by cell culture and/or RT-PCR [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Peak viral shedding titer by cell culture and/or RT-PCR [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Time to resolution from peak viral shedding by cell culture and/or RT-PCR [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Time to peak of composite sympton score, duration, and time to resolution of composite score from peak [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Peak severity of symptoms after viral inoculation [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Duration of influenza-like illness after viral inoculation [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza Virus
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Influenza Virus
  • Drug: VX-787
    low dose capsule, taken orally for 5 days
  • Drug: VX-787
    high dose capsule, taken orally for 5 days
  • Experimental: 787 low dose
    Intervention: Drug: VX-787
  • Experimental: 787 high dose
    Intervention: Drug: VX-787
  • Experimental: Placebo low dose
    Capsule matching the low dose
    Intervention: Drug: VX-787
  • Experimental: Placebo high dose
    Capsule matching the high dose
    Intervention: Drug: VX-787
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
Not Provided
October 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01561807
VX11-787-101
No
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Not Provided
Study Director: Jose Trevejo, MD, PhD Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP