Respiratory Syncytial Virus MedDRA version: 20.0 Level: HLT Classification code 10038717 Term: Respiratory syncytial viral infections System Organ Class: 100000004862
Conditions
Interventions
Product Name: JNJ-53718678 (G024)
Pharmaceutical Form: Oral solution
INN or Proposed INN: JNJ-53718678-AAA
CAS Number: 1383450-81-4
Current Sponsor code: JNJ-53718678-AAA
Concentration unit: mg/ml mil
Sponsors
Janssen Sciences Ireland UC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female. 2. =18 years of age. Note: If the legal age of consent in the jurisdiction in which the study is taking place is >18 years, this respective legal age is binding for eligibility. 3. Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study. Note: Prior to signing the main consent form for the study, subjects may specifically allow for the collection and testing of nasal mid-turbinate swabs by signing the pre screening (diagnostic) ICF. 4. Subjects 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 =5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the subject becomes aware of the first sign and/or symptom consistent with a viral infection. Efforts should be made to determine the time of onset of symptoms as accurately as possible (in relation to routine daily activities). Note: The viral infection may present in any way as long as the underlying precipitant of the illness is considered by the investigator to be due to RSV infection. Examples of such an illness include: - An upper or lower viral respiratory tract infection (eg, “flu-like illness”); - Pneumonia; - Respiratory distress; - Asthma exacerbation; - COPD exacerbation. 5. Subject has been diagnosed with RSV infection using a rapid polymerase chain reaction (PCR) based (preferably locally available) or rapid-antigen-detection test. Note: If a patient has a positive similar diagnostic test from another study and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for confirmation of eligibility. Please refer to the protocol for other inclusion criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the study: 1. Hospitalized subjects or subjects expected to be hospitalized within 24 hours of screening. Note: Any stay in the emergency room or in the observational unit of at least 24 hours will be considered hospitalization for the purposes of the study. 2. 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 subject or that could prevent, limit, or confound the protocol-specified assessments. 3. Subjects who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study. 4. Subjects who are considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition (eg, malignancy or genetic disorder other than immunoglobulin A deficiency, or human immunodeficiency virus [HIV] infection) or medical therapy (eg, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant). 5. Subject has known or suspected chronic or acute hepatitis B or C infection. Please refer to the protocol for other exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 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.;Secondary Objective: - To explore in adults with RSV infection, after repeated oral dosing with JNJ-53718678: a) The safety and tolerability of JNJ-53718678; b) The impact of JNJ-53718678 on the clinical course of RSV infection; c) The pharmacokinetics of JNJ-53718678. ;Primary end point(s): 1. Area Under the Respiratory Syncytial Virus (RSV) Viral Load-time Curve (AUC) 2. RSV Viral Load and Change From Baseline Over Time 3. Time to Undetectable RSV Viral Load 4. Proportion of Subjects With Undetectable RSV Viral Load at Each Time Point;Timepoint(s) of evaluation of this end point: 1. Baseline through Day 3, Day 5, Day 8, and Day 14 2, 3, & 4. Throughout the study (Approximately 29 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety and Tolerability, as Assessed by Adverse Events (AEs), Clinical Laboratory Testing, ECGs, Vital Signs, Physical Examination 2. Duration and Severity of Signs and Symptoms of RSV Infection Assessed Through an Instrument for Patient-Reported Symptoms (either the Respiratory Infection-Patient Reported Outcomes [RI PRO] Questionnaire or the Respiratory Infection Intensity and Impact Questionnaire [RiiQ] questionnaire) and Additional Questions About Health and Functioning 3. Time to Alleviation of Selected RSV Symptoms as Reported by the Subject 4. Respiratory Rate 5. Heart Rate 6. Body Temperature 7. Peripheral Capillary Oxygen Saturation (SpO2) 8. Predose Plasma Concentration (Ctrough) JNJ-53718678 9. Maximum Observed Concentration (Cmax) of JNJ-53718678 ;Timepoint(s) of evaluation of this end point: 1. At baseline, Day 3, 8, 14, 21 and 28. 2. Till Day 21 3. Day 1 to 14 and Day 21 4 to 7. At baseline, Day 2 to 8, Day 14, 21 and 28. 8 & 9. Day 3 and Day 8 Exploratory End points: 1 to 9. At baseline and throughout the study (Approximately 29 days) | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Japan, Korea, Democratic People's Republic of, Malaysia, Mexico, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry group
Janssen-Cilag International N.V.
Outcome results
None listed