Influenza A MedDRA version: 19.0 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862
Conditions
Interventions
Product Name: VX-787
Product Code: VX-787
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-787
Other descriptive name: VX-787
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Willing and able to comply with study requirements including treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures. • Subjects have an oral temperature of =38°C (100.4°F) within the prior 24 hours and at least 1 respiratory and at least 1 systemic symptom • Subjects have a documented oral temperature of =38°C (100.4°F) during the screening visit unless antipyretic medication had been administered within the past 6 hours, in which case a normal temperature at screening is acceptable, so long as the patient had a fever =38°C at some time prior to taking the medication , and at least 1 respiratory and at least 1 systemic symptom, both scored as at least “moderate” when self-assessed with a symptom assessment scale. • The onset of flu-like symptoms must be =48 hours before receiving study drug. • Subjects must be positive for influenza A with a rapid influenza diagnostic test 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 500 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any history of illness, comorbidity or lab abnormality, particularly pulmonary, cardiac or diabetes that might confound the results of the study or pose an additional risk in administering study drug to the subject. • Use of a live attenuated intranasal spray vaccine (e.g. Flumist©) in the 3 weeks before study entry. • Subjects who have taken antiviral medication within 14 days before screening. • Pregnant and nursing females, sexually active subjects or reproductive potential who are not willing to follow the contraception requirements. • Subjects may not participate in an investigational study drug until the completion of this study. • Subjects with bacterial infections requiring systemic antibacterial agents at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The key secondary objective is to evaluate the time to resolution of influenza symptoms in adults with acute uncomplicated seasonal influenza A following administration of VX-787, with and without concomitant oseltamivir. Other secondary objectives are to evaluate: • Safety and tolerability of administration of VX-787 with and without concurrent oseltamivir in adults with acute uncomplicated seasonal influenza A • Antiviral effect, as measured by viral titer in nasal secretions, of administration of VX-787 in combination with oseltamivir in adults with acute uncomplicated seasonal influenza A • Change in the duration and severity of clinical symptoms • Pharmacokinetics of VX-787, administered as a monotherapy and in combination with oseltamivir • Assessment of viral sequences for changes that may be associated with resistance to VX-787 and/or oseltamivir;Main Objective: The primary objectives of the study is to evaluate the antiviral effect, as measured by viral titer in nasal secretions in adults with acute uncomplicated seasonal influenza A following administration of VX-787.;Primary end point(s): The primary endpoint is the area under the curve (AUC) of the log10 nasal viral load measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR), from baseline to Day 8. ;Timepoint(s) of evaluation of this end point: From baseline to day 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint is the time from initiation of study drug to resolution of influenza A symptoms. Other secondary endpoints: • Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs • Antiviral effect and viral kinetics in relation to: o Duration of viral shedding in nasal secretions by qRT-PCR and viral culture o AUC of the log10 viral load measured by viral culture o Peak viral shedding titer by qRT-PCR and viral culture • Clinical symptom scores o Composite symptom score AUC o Time to peak of composite symptom score, o Duration and time to resolution of composite symptom score from peak • PK parameters of VX-787, as determined by population analysis • Viral sequence to monitor for emergence of viral variants resistant to VX 787 and to oseltamivir;Timepoint(s) of evaluation of this end point: Through day 14 | — |
Countries
Belgium, Bulgaria, Canada, Estonia, Germany, Latvia, South Africa, United States
Contacts
Public ContactClinical Trials and Medical Info
Vertex Pharmaceuticals Incorporated
Outcome results
None listed