NCT02342249

Study 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Influenza A

Interventions

Type	Name	Description
DRUG	VX-787 300 mg	A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.
DRUG	VX-787 600 mg	A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days.
DRUG	Oseltamivir 75 mg	A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.
DRUG	Placebo	Subjects will receive matching placebo of Oseltamivir

Timeline

• Start date: 2014-12-11
• Primary completion: 2016-05-25
• Completion: 2016-05-25
• First posted: 2015-01-19
• Last updated: 2025-02-04

Locations

176 sites across 9 countries: United States, Belgium, Bulgaria, Canada, Estonia, Germany, Latvia, Puerto Rico, South Africa

Regulatory

• FDA-regulated drug study