A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection

NCT02532283 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-03-27

Study results available
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Summary

The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to \<= 85 years) compared to adults (aged 18 to \<= 64 years) with influenza A infection.

Conditions

  • Influenza A Virus

Interventions

DRUG

JNJ-63623872

Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.

DRUG

Placebo

Participants will be administered placebo tablets orally twice daily for 7 days.

DRUG

Oseltamivir

Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.

Sponsors & Collaborators

  • 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
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-11
Primary Completion
2017-02-24
Completion
2017-03-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Hong Kong
  • Malaysia
  • Netherlands
  • New Zealand
  • Singapore
  • Spain
  • Sweden
  • Turkey (Türkiye)

Study Locations

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Entities

Drugs

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 NCT02532283 on ClinicalTrials.gov