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
Condition: Influenza A Virus
MeSH terms: Influenza, Human
Intervention: JNJ-63623872; Placebo; Oseltamivir
Intervention description: Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.; Participants will be administered placebo tablets orally twice daily for 7 days.; Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
Intervention MeSH terms: Oseltamivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Influenza A virus; JNJ-63623872; Oseltamivir

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.
    

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