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The purpose of this study is to determine the antiviral activity and safety of VX-787 given to healthy adult volunteers that have been inoculated with the influenza virus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 787 low dose | Experimental | VX-787 low dose capsule, taken orally for 5 days |
|
| 787 high dose | Experimental | VX-787 high dose capsule, taken orally for 5 days |
|
| Placebo low dose | Experimental | Matching placebo low dose capsule, taken orally for 5 days |
|
| Placebo high dose | Experimental | Matching placebo high dose capsule, taken orally for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-787 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs. | up to 33 days | |
| Total tissue count and total mucus weight after viral inoculation | up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Trevejo, MD, PhD | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | United Kingdom |
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| ID | Term |
|---|---|
| C000605010 | pimodivir |
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|
| Sequence analysis of the relevant target region of influenza | up to 8 days |
| Pharmacokinetic (PK) parameters of VX-787 | As measured by AUC, Cmax, tmax | 8 days |
| Composite symptom score AUC | up to 8 days |
| Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment | up to 8 days |
| Duration of viral shedding by cell culture and/or RT-PCR | up to 8 days |
| Peak viral shedding titer by cell culture and/or RT-PCR | up to 8 days |
| Time to resolution from peak viral shedding by cell culture and/or RT-PCR | up to 8 days |
| Time to peak of composite sympton score, duration, and time to resolution of composite score from peak | up to 8 days |
| Peak severity of symptoms after viral inoculation | up to 8 days |
| Duration of influenza-like illness after viral inoculation | up to 8 days |