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

NCT ID: NCT02532283

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-11
• Study Completion Date: 2017-03-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ-63623872 plus Oseltamivir

Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.

Group Type: EXPERIMENTAL

JNJ-63623872

Intervention Type: DRUG

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

Oseltamivir

Intervention Type: DRUG

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

Placebo plus Oseltamivir

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

Oseltamivir

Intervention Type: DRUG

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

Interventions

JNJ-63623872

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Oseltamivir

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant requires hospitalization to treat influenza infection and/or to treat complications of influenza infection
• Participant tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reaction (PCR)-based rapid molecular diagnostic assay
• Participants must be capable of swallowing study medication tablets and capsules
• Each participant (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
• Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol

Exclusion Criteria

• Participant received more than 3 doses of the influenza antiviral medication oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or ribavirin within 6 months prior to Screening
• Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens
• Participant is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant)
• Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration
• Participant has an estimated glomerular filtration rate (eGFR) less than or equal to (<=)30 milliliter (mL)/minute (min)/1.73 meter^2 (m^2) according to the Modification of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most recent clinically relevant creatinine value if available

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Fresno, California, United States

Long Beach, California, United States

Stanford, California, United States

Atlantis, Florida, United States

Miami, Florida, United States

Chicago, Illinois, United States

Detroit, Michigan, United States

Royal Oak, Michigan, United States

Troy, Michigan, United States

Minneapolis, Minnesota, United States

St Louis, Missouri, United States

Teaneck, New Jersey, United States

Winston-Salem, North Carolina, United States

Houston, Texas, United States

Cairns, , Australia

South Brisbane, , Australia

Westmead, , Australia

Aalst, , Belgium

Brussels, , Belgium

Leuven, , Belgium

Passo Fundo, , Brazil

Porto Alegre, , Brazil

São Paulo, , Brazil

Hamilton, Ontario, Canada

Québec, Quebec, Canada

Dijon, , France

Grenoble, , France

Limoges, , France

Lyon, , France

Nantes, , France

Paris, , France

Poitiers, , France

Rennes, , France

Saint-Priest-en-Jarez, , France

Tours, , France

Donaustauf, , Germany

Jena, , Germany

Hong Kong, , Hong Kong

Kota Bharu, , Malaysia

Kuala, , Malaysia

Kuala Lumpur, , Malaysia

Kuching, , Malaysia

Malacca, , Malaysia

Miri, , Malaysia

Sungai Buloh, , Malaysia

Taiping, , Malaysia

Rotterdam, , Netherlands

Utrecht, , Netherlands

Zutphen, , Netherlands

Hamilton, , New Zealand

Singapore, , Singapore

Alicante, , Spain

Barcelona, , Spain

Bizkaia, , Spain

Elche, , Spain

Granada, , Spain

Madrid, , Spain

Mataró, , Spain

San Sebastián, , Spain

Vigo, , Spain

Malmo, , Sweden

Umeå, , Sweden

Uppsala, , Sweden

Ankara, , Turkey (Türkiye)

Eskişehir, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Trabzon, , Turkey (Türkiye)

Countries

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

References

O'Neil B, Ison MG, Hallouin-Bernard MC, Nilsson AC, Torres A, Wilburn JM, van Duijnhoven W, Van Dromme I, Anderson D, Deleu S, Kosoglou T, Vingerhoets J, Rossenu S, Leopold L. A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study. J Infect Dis. 2022 Aug 12;226(1):109-118. doi: 10.1093/infdis/jiaa376.

Reference Type: DERIVED

PMID: 32604406 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-003002-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

63623872FLZ2002

Identifier Type: OTHER

Identifier Source: secondary_id

CR107746

Identifier Type: -

Identifier Source: org_study_id