The purpose of this 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
292
A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.
A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days.
A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.
Area under the curve (AUC) of the log10 Nasal Viral Load on Day 8
Area under the curve (AUC) of the log10 nasal viral load is measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).
Time frame: Day 8
Time to Resolution of Influenza Symptoms After Initiation of Study Drug
Estimated acceleration factors expressed as the ratio of the time to resolution of influenza symptoms as compared to placebo time to negativity. Resolution of influenza symptoms was the time of the first of 3 evaluations (over 24 hours) in which all symptom scores for each of the 3 assessments are 0 or 1 for all 7 primary influenza symptoms (cough, sore throat, headache, nasal stuffiness, feverishness or chills, muscle or joint pain, and fatigue) of the Flu-iiQ\^TM. The Flu-iiQ\^TM questionnaire consists of 4 modules, including 1 module assessing influenza symptoms, 1 module assessing the impact of influenza on normal functioning, and 2 modules assessing the impact of influenza on the subject's emotional state. The Influenza Symptom assessment (Module 1) is scored on a 4 point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) for each of 10 influenza symptoms.
Time frame: Baseline up to Day 14
Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs
Time frame: Day 14
Antiviral effect and viral kinetics composite
Antiviral effect and viral kinetics in relation to: * Duration of viral shedding in nasal secretions by qRT-PCR and viral culture * AUC of the log10 viral load measured by viral culture * Peak viral shedding titer by qRT-PCR and viral culture.
Time frame: Days 1 - 8
Clinical composite symptom scores
Clinical symptom scores * Composite symptom score AUC * Time to peak of composite symptom score, * Duration and time to resolution of composite symptom score from peak
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Subjects will receive matching placebo of Oseltamivir
Unnamed facility
Athens, Alabama, United States
Unnamed facility
Birmingham, Alabama, United States
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Gulf Shores, Alabama, United States
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Huntsville, Alabama, United States
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Scottsboro, Alabama, United States
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Harrisburg, Arkansas, United States
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Phoenix, Arkansas, United States
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Anaheim, California, United States
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Burbank, California, United States
Unnamed facility
Canoga Park, California, United States
...and 166 more locations
Time frame: Day 14
Pharmacokinetic parameters of VX787, as determined by population analysis
A population Pharmacokinetic Pharmacodynamic analysis of plasma concentration data of VX-787 will be performed using the nonlinear mixed effects modeling approach.
Time frame: Day 14
Viral sequence analysis to monitor for emergence of viral variants resistant to VX 787 and to oseltamivir
Time frame: Day 14