Clinical trial NCT01561807: A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza Virus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza Virus
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
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
timeFrame: up to 11 days
Secondary outcomes:
measure: Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs.
timeFrame: up to 33 days
measure: Total tissue count and total mucus weight after viral inoculation
timeFrame: up to 10 days
measure: Sequence analysis of the relevant target region of influenza
timeFrame: up to 8 days
measure: Pharmacokinetic (PK) parameters of VX-787
timeFrame: 8 days
measure: Composite symptom score AUC
timeFrame: up to 8 days
measure: Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment
timeFrame: up to 8 days
measure: Duration of viral shedding by cell culture and/or RT-PCR
timeFrame: up to 8 days
measure: Peak viral shedding titer by cell culture and/or RT-PCR
timeFrame: up to 8 days
measure: Time to resolution from peak viral shedding by cell culture and/or RT-PCR
timeFrame: up to 8 days
measure: Time to peak of composite sympton score, duration, and time to resolution of composite score from peak
timeFrame: up to 8 days
measure: Peak severity of symptoms after viral inoculation
timeFrame: up to 8 days
measure: Duration of influenza-like illness after viral inoculation
timeFrame: up to 8 days
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Jose Trevejo, MD, PhD
role: STUDY_DIRECTOR
References: