Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02342249 | Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects | PHASE2 | COMPLETED | 292 | — | — | Dec 11, 2014 | May 25, 2016 | Feb 4, 2025 | 176 | United States, Belgium +7 |
Area under the curve (AUC) of the log10 nasal viral load is measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).
| Arm | Type | Description |
|---|---|---|
| VX-787 Placebo BID + Oseltamivir Placebo BID | PLACEBO_COMPARATOR | Subjects will receive 10 doses of matching placebo of VX-787 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| VX-787 300 mg BID + Oseltamivir Placebo BID | ACTIVE_COMPARATOR | Subjects will receive 10 doses of VX-787 300 milligram (mg) tablet along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| VX-787 600 mg BID + Oseltamivir Placebo BID | ACTIVE_COMPARATOR | Subjects will receive 10 doses of VX-787 600 mg (2\*300 mg tablets) along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| VX-787 600 mg BID + Oseltamivir 75 mg BID | ACTIVE_COMPARATOR | Subjects will receive 10 doses of VX-787 600 mg tablets (2\*300 mg tablets) along with 75 mg Oseltamivir capsule twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| Name | Type | Description |
|---|---|---|
| VX-787 300 mg | DRUG | A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days. |
| VX-787 600 mg | DRUG | A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days. |
| Oseltamivir 75 mg | DRUG | A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days. |
| Placebo | DRUG | Subjects will receive matching placebo of Oseltamivir |
Inclusion Criteria: Part A 1. Willing and able to comply with the NP swab procedure 2. Subject will sign and date an informed consent form (ICF) 3. Presenting to the clinic with symptoms suggestive of a diagnosis of acute influenza. Symptoms include oral temperature ≥38°C (100.4°F) within the prior...