London, United Kingdom
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
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
DrugPlacebo
DrugPrimary outcomes
-
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
-
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
-
Total tissue count and total mucus weight after viral inoculation
Time frame: up to 10 days
-
Sequence analysis of the relevant target region of influenza
Time frame: up to 8 days
-
Pharmacokinetic (PK) parameters of VX-787
Time frame: 8 days
As measured by AUC, Cmax, tmax
-
Composite symptom score AUC
Time frame: up to 8 days
-
Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment
Time frame: up to 8 days
-
Duration of viral shedding by cell culture and/or RT-PCR
Time frame: up to 8 days
-
Peak viral shedding titer by cell culture and/or RT-PCR
Time frame: up to 8 days
-
Time to resolution from peak viral shedding by cell culture and/or RT-PCR
Time frame: up to 8 days
-
Time to peak of composite sympton score, duration, and time to resolution of composite score from peak
Time frame: up to 8 days
-
Peak severity of symptoms after viral inoculation
Time frame: up to 8 days
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
NCT01964989
Infections, Influenza Virus
Chandler, Arizona, United States
View Trial DetailsIntradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
NCT00760175
Infections, Influenza Vaccine
Edmonton, Alberta, Canada
View Trial DetailsSurveillance of Influenza Virus Shedding and Immunologic Response in Immunocompromised Children and Young Adults
NCT00998803
Influenza Virus
Memphis, Tennessee, United States
View Trial DetailsCOMMUNITY - the COVID-19 Immunity Study
NCT06784739
COVID 19, COVID-19
Stockholm, Sweden
View Trial Details