MedTrace Logo

Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects

NCT02342249 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2025-02-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-11
Primary Completion
2016-05-25
Completion
2016-05-25
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Estonia
  • Germany
  • Latvia
  • Puerto Rico
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02342249 on ClinicalTrials.gov