A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study of 2 Dose Levels of VX 787 Administered as Monotherapy and One Dose Level of VX-787 Administered in Combination With Oseltamivir for the Treatment of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study of 2 Dose Levels of VX 787 Administered as Monotherapy and One Dose Level of VX-787 Administered in Combination With Oseltamivir for the Treatment of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
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.
Inclusion Criteria: Part A
Part B
Exclusion Criteria: Part B
History of any illness or any clinical condition that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal tract surgery, except appendectomy).
Immunized (intranasal or injected vaccine) against influenza in the 6 months before study entry.
At Screening, an ECG that is abnormal and deemed by the investigator(s) to be clinically significant.
For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol.
For male subjects, unwilling to comply with contraception requirements as outlined in the study protocol.
Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the first study drug dose.
Use of the following medications:
History of excessive alcohol consumption.
History of known or current usage of drugs of abuse.
Hospitalized subjects and subjects with bacterial infections requiring systemic antibacterial agents at the time of screening.
Phoenix, Arkansas, United States
Belton, Michigan, United States