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



Status:Recruiting
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:February 6, 2018
End Date:November 3, 2020
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus

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.

This study will be performed to explore the antiviral activity, clinical outcomes, safety,
tolerability, and pharmacokinetics of JNJ-53718678 in adult participants infected with RSV.
The study will include both participants who are otherwise healthy (ie, without underlying
condition) or who have comorbid conditions (eg, asthma, chronic obstructive pulmonary disease
(COPD), cardiovascular disease, other chronic diseases), with the exception of
immunocompromised participants, presenting for medical care but not requiring
hospitalization. The study will include a screening period (Day -1 to Day 1), a treatment
Period (Day 1 to Day 8), and a follow-up period (Day 9 to Day 28). Safety evaluations will
include adverse events, laboratory tests, electrocardiogram, vital signs, physical
examination, and specific toxicities.

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
We found this trial at
14
sites
3165 East Greenhurst Road
Nampa, Idaho 83686
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Nampa, ID
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Bahia Blanca,
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Butte, Montana 59701
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Butte, MT
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Cerritos, California 90703
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Cerritos, CA
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Charlotte, North Carolina 28210
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Charlotte, NC
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Chula Vista, California 91911
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Chula Vista, CA
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Eustis, Florida 32726
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Eustis, FL
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Gaffney, South Carolina 29341
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Gaffney, SC
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Garden Grove, California 92844
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Garden Grove, CA
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3700 North Classen Boulevard
Lindsay, Oklahoma 73052
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Lindsay, OK
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10555 West Flagler Street
Miami, Florida 33174
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Miami, FL
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800 E 28th St
Minneapolis, Minnesota 55407
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Minneapolis, MN
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Royal Oak, Michigan 48073
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Royal Oak, MI
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101 East Wood Street
Spartanburg, South Carolina 29301
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Spartanburg, SC
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