Influenza A MedDRA version: 14.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: VX-787
Product Code: VX-787
Pharmaceutical Form: Capsule
Current Sponsor code: VX-787
Other descriptive name: VX-787
Concentration unit: mg milligram(s)
Concentration type: range
Concent
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy male and female subjects - Negative human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) antibody screen - Negative Class A drugs and alcohol screen before dosing - Serosuitable for the challenge strain of influenza A - 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 - Willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, contraceptive guidelines, and other study procedures, including willingness to enter and remain in quarantine (in isolation for approximately 10 days) until free of influenza infection, as determined by rapid antigen test or clinical evaluation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects who are male and their female partner (if of childbearing potential) does not agree to use medically approved methods of contraception - 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 - 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 challenge) - 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, chronic obstructive pulmonary disease, or any use of a bronchodilator or other asthma medication during adulthood -Regular daily smokers during the 6 months before study entry or those who have a significant history of any tobacco use at any time - History of heart failure or any other severe cardiac abnormality including clinically significant arrhythmia - Use of any prescription drugs, herbal supplements, within 4 weeks before drug IMP administration, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks before viral challenge. - 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 the IMP or similar substance(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the effect of oral administration of VX 787 administered post-inoculation on the AUC of viral titers quantified by nasal swab cell culture in a human challenge model of influenza.;Secondary Objective: - Safety and tolerability of VX 787 in healthy adult subjects inoculated with live influenza virus - Safety of the GMP manufactured influenza virus inoculum strain in susceptible, healthy subjects receiving either VX 787 or placebo - Influenza viral kinetics from nasal swabs by RT PCR - Change and severity of clinical symptoms - Changes in the sequence of the relevant target region of influenza in nasal swabs - Pharmacokinetics of VX 787;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs - Viral kinetics in relation to: o Viral AUC calculated by cell culture and/or RT-PCR o Duration of viral shedding by cell culture and/or RT-PCR o Peak viral shedding titre by cell culture and/or RT-PCR o Time to resolution from peak viral shedding by cell culture and/or RT-PCR - Clinical symptom scores o Composite symptom score AUC o Time to peak of composite symptom score, duration, and time to resolution of composite score from peak o Peak severity symptoms after influenza viral inoculation o Duration of influenza-like illness after influenza viral inoculation - Total tissue count and total mucus weight post challenge - Sequence analysis of the relevant target region of influenza - Pharmacokinetic parameters of VX 787 (AUC, Cmax, Cmin, tmax) ;Timepoint(s) of evaluation of this end point: up to 28 Days | — |
Countries
United Kingdom
Contacts
Public ContactMedical Information Center
Vertex Pharmaceuticals Incorporated
Outcome results
None listed