NCT02532283

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

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the effect of JNJ-63623872 in combination with oseltamivir in participants with influenza A infection. The study consists of 3 Phases: Screening visit (1 Day), participants who meet all eligibility criteria will be randomized in a 2:1 ratio to receive study drug in double-blind treatment Phase (7 Days) and follow up Phase (21 Days). The duration of participation in the study for each participant is approximately 28 Days. Primarily Pharmacokinetic parameters of JNJ-63623872 will be measured. Participants' safety will be monitored throughout the study.

Conditions

• Influenza A Virus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-11
• Primary completion: 2017-02-24
• Completion: 2017-03-15
• First posted: 2015-08-25
• Last updated: 2020-03-27
• Results posted: 2020-03-27

Locations

68 sites across 15 countries: United States, Australia, Belgium, Brazil, Canada, France, Germany, Hong Kong, Malaysia, Netherlands, New Zealand, Singapore, Spain, Sweden, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study