A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: JNJ-53718678 500 mg; JNJ-53718678 80 mg; Placebo
Intervention description: Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.; Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.; In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels
      (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial
      Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative
      reverse transcription polymerase chain reaction (qRT-PCR) assay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have an acute respiratory illness with signs and symptoms consistent
             with a viral infection (example, fever, cough, nasal congestion, runny nose, sore
             throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or
             equal to 5 days from the anticipated time of randomization. Onset of symptoms is
             defined as the time the participant becomes aware of the first sign and/or symptom
             consistent with a viral infection

          -  Participant has been diagnosed with respiratory syncytial virus (RSV) infection using
             a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test

          -  Before randomization, a woman must be not of childbearing potential defined as:
             Premenarchal, Postmenopausal or Permanently sterile

          -  A male participant must agree to the use of acceptable contraceptive measures

          -  With the exception of the RSV-related illness the participant must be medically stable
             on the basis of physical examination, medical history, vital signs, and
             electrocardiogram (ECG) performed at screening

        Exclusion Criteria:

          -  Hospitalized participants or participants expected to be hospitalized within 24 hours
             of screening

          -  History of or concurrent illness (beyond a comorbid condition) that in the opinion of
             the investigator, might confound the results of the study or pose an additional risk
             in administering study drug to the participant or that could prevent, limit, or
             confound the protocol-specified assessments

          -  Participants who had major surgery within the 28 days prior to randomization or have
             planned major surgery through the course of the study

          -  Participants who are considered by the investigator to be immunocompromised within the
             past 12 months

          -  Participant has known or suspected chronic or acute hepatitis B or C infection

          -  Women who are pregnant or breastfeeding

          -  Participants with clinically significant abnormal ECG findings (other than QT-interval
             corrected for heart rate according to Fridericia [QTcF] interval greater than [>] 500
             millisecond [ms]) not consistent with the underlying condition in the study
             population, as judged by the investigator