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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

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ClinicalTrials.gov Identifier: NCT03379675
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: JNJ-53718678 500 mg Drug: JNJ-53718678 80 mg Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : June 3, 2020
Estimated Study Completion Date : June 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A: JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.
Drug: JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.

Experimental: Treatment B: JNJ-53718678 80 mg + Placebo
Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Drug: JNJ-53718678 80 mg
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.

Drug: Placebo
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.

Placebo Comparator: Treatment C: Placebo
Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Drug: Placebo
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.




Primary Outcome Measures :
  1. Area Under the Viral Load-time Curve (AUC) [ Time Frame: Baseline up to Day 3 ]
    Viral load (VL) AUC will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs.

  2. Area Under the Viral Load-time Curve (AUC) [ Time Frame: Baseline up to Day 5 ]
    Viral load (VL) AUC will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs.

  3. Area Under the Viral Load-time Curve (AUC) [ Time Frame: Baseline up to Day 8 ]
    Viral load (VL) AUC will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs.

  4. Area Under the Viral Load-time Curve (AUC) [ Time Frame: Baseline up to Day 14 ]
    Viral load (VL) AUC will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs.

  5. RSV (Respiratory Syncytial Virus) Viral Load Over Time [ Time Frame: Up to Day 21 ]
    RSV viral load over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  6. Change from Baseline in RSV Viral Load Over Time [ Time Frame: Baseline up to Day 21 ]
    Change from baseline in RSV viral load over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  7. Time to Undetectable RSV Viral Load [ Time Frame: Up to Day 21 ]
    Time (hours) to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

  8. Proportion of Participants with Undetectable RSV Viral Load [ Time Frame: Up to Day 21 ]
    Proportion of participants with undetectable RSV viral load will be reported.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to Day 28 ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  2. Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Findings [ Time Frame: Up to Day 28 ]
    Number of participants with abnormalities in vital signs, physical examinations, ECG and laboratory findings will be measured.

  3. Duration of Signs and Symptoms of RSV Infection as Assessed by RI-PRO Questionnaire [ Time Frame: Up to Day 21 ]
    Duration of signs and symptoms of RSV infection assessed through an instrument for patient-reported symptoms (the Respiratory Infection-Patient Reported Outcomes [RI-PRO] questionnaire). RI-PRO score ranges from 0 (not at all) to 4 (very much).

  4. Severity of Signs and Symptoms of RSV Infection as Assessed by RI-PRO Questionnaire [ Time Frame: Up to Day 21 ]
    Severity of signs and symptoms of RSV infection assessed through an instrument for patient-reported symptoms (RI-PRO questionnaire). RI-PRO score ranges from 0 (not at all) to 4 (very much).

  5. Duration of Signs and Symptoms of RSV Infection as Assessed by RiiQ Questionnaire [ Time Frame: Up to Day 21 ]
    Duration of signs and symptoms of RSV infection assessed through an instrument for patient-reported symptoms (the Respiratory Infection Intensity and Impact Questionnaire [RiiQ] questionnaire). RiiQ score ranges from 0 (not at all) to 3 (very much).

  6. Severity of Signs and Symptoms of RSV Infection as Assessed by RiiQ Questionnaire [ Time Frame: Up to Day 21 ]
    Severity of signs and symptoms of RSV infection assessed through an instrument for patient-reported symptoms (RiiQ questionnaire). RiiQ score ranges from 0 (not at all) to 3 (very much).

  7. Time to Resolution of Selected RSV Symptoms as Assessed by RI-PRO Questionnaire [ Time Frame: Up to Day 21 ]
    Time to resolution of selected RSV symptoms will be assessed through an instrument for patient-reported symptoms (RI-PRO questionnaire). RI-PRO score ranges from 0 (not at all) to 4 (very much).

  8. Time to Resolution of Selected RSV Symptoms as Assessed by RiiQ Questionnaire [ Time Frame: Up to Day 21 ]
    Time to resolution of selected RSV symptoms will be assessed through an instrument for patient-reported symptoms (RiiQ questionnaire). RiiQ score ranges from 0 (not at all) to 3 (very much).

  9. Change from Baseline in Respiratory Rate [ Time Frame: Baseline up to Day 28 ]
    Respiratory rate (number of breaths per minute) will be assessed by the investigator.

  10. Change from Baseline in Heart Rate [ Time Frame: Baseline up to Day 28 ]
    Heart Rate (beats per minute) will be assessed by the investigator.

  11. Change from Baseline in Body Temperature [ Time Frame: Baseline up to Day 28 ]
    Body temperature (degrees Celsius) will be assessed by the investigator.

  12. Change from Baseline in Peripheral Capillary Oxygen Saturation (SpO2) [ Time Frame: Baseline up to Day 28 ]
    Change from baseline in Peripheral Capillary Oxygen Saturation (SpO2) will be assessed by the investigator.

  13. Plasma Concentrations of JNJ-53718678 [ Time Frame: Day 3 and Day 8 ]
    Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379675


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03379675     History of Changes
Other Study ID Numbers: CR108419
2017-003252-24 ( EudraCT Number )
53718678RSV2004 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Antiviral Agents
Anti-Infective Agents