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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03379675




Registration number
NCT03379675
Ethics application status
Date submitted
15/12/2017
Date registered
20/12/2017
Date last updated
19/09/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2017-003252-24
Secondary ID [2] 0 0
CR108419
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-53718678 500 mg
Treatment: Drugs - JNJ-53718678 80 mg
Treatment: Drugs - Placebo

Experimental: Treatment A: JNJ-53718678 500 mg - Participants will receive 500 mg dose of JNJ-53718678 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.

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.


Treatment: Drugs: JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3
Timepoint [1] 0 0
Baseline through Day 3
Primary outcome [2] 0 0
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
Timepoint [2] 0 0
Baseline through Day 5
Primary outcome [3] 0 0
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
Timepoint [3] 0 0
Baseline through Day 8
Primary outcome [4] 0 0
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
Timepoint [4] 0 0
Baseline through Day 14
Primary outcome [5] 0 0
Change From Baseline in RSV Viral Load at Day 3
Timepoint [5] 0 0
Baseline to Day 3
Primary outcome [6] 0 0
Change From Baseline in RSV Viral Load at Day 5
Timepoint [6] 0 0
Baseline to Day 5
Primary outcome [7] 0 0
Change From Baseline in RSV Viral Load at Day 8
Timepoint [7] 0 0
Baseline to Day 8
Primary outcome [8] 0 0
Change From Baseline in RSV Viral Load at Day 14
Timepoint [8] 0 0
Baseline to Day 14
Primary outcome [9] 0 0
Change From Baseline in RSV Viral Load at Day 21
Timepoint [9] 0 0
Baseline to Day 21
Primary outcome [10] 0 0
RSV Viral Load at Baseline
Timepoint [10] 0 0
Baseline
Primary outcome [11] 0 0
RSV Viral Load at Day 3
Timepoint [11] 0 0
Day 3
Primary outcome [12] 0 0
RSV Viral Load at Day 5
Timepoint [12] 0 0
Day 5
Primary outcome [13] 0 0
RSV Viral Load at Day 8
Timepoint [13] 0 0
Day 8
Primary outcome [14] 0 0
RSV Viral Load at Day 14
Timepoint [14] 0 0
Day 14
Primary outcome [15] 0 0
RSV Viral Load at Day 21
Timepoint [15] 0 0
Day 21
Primary outcome [16] 0 0
Time to Undetectable RSV Viral Load
Timepoint [16] 0 0
Up to Day 21
Primary outcome [17] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 3
Timepoint [17] 0 0
Day 3
Primary outcome [18] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 5
Timepoint [18] 0 0
Day 5
Primary outcome [19] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 8
Timepoint [19] 0 0
Day 8
Primary outcome [20] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 14
Timepoint [20] 0 0
Day 14
Primary outcome [21] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 21
Timepoint [21] 0 0
Day 21
Secondary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Timepoint [1] 0 0
Up to Day 28
Secondary outcome [2] 0 0
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities
Timepoint [2] 0 0
Up to Day 28
Secondary outcome [3] 0 0
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities
Timepoint [3] 0 0
Up to Day 28
Secondary outcome [4] 0 0
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities
Timepoint [4] 0 0
Up to Day 28
Secondary outcome [5] 0 0
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Timepoint [5] 0 0
Baseline, Days 3, 8, 14, and 21
Secondary outcome [6] 0 0
Change From Baseline in Peripheral Capillary Oxygen Saturation
Timepoint [6] 0 0
Baseline to Days 3, 8, 14 and 21
Secondary outcome [7] 0 0
Pulse Rate Over Time
Timepoint [7] 0 0
Baseline, Days 3, 8, 14 and 21
Secondary outcome [8] 0 0
Change From Baseline in Pulse Rate
Timepoint [8] 0 0
Baseline to Days 3, 8, 14 and 21
Secondary outcome [9] 0 0
Respiratory Rate Over Time
Timepoint [9] 0 0
Baseline, Days 3, 8, 14 and 21
Secondary outcome [10] 0 0
Change From Baseline in Respiratory Rate
Timepoint [10] 0 0
Baseline to Days 3, 8, 14 and 21
Secondary outcome [11] 0 0
Body Temperature Over Time
Timepoint [11] 0 0
Baseline, Days 3, 8, 14 and 21
Secondary outcome [12] 0 0
Change From Baseline in Body Temperature
Timepoint [12] 0 0
Baseline to Days 3, 5, 8, 14 and 21
Secondary outcome [13] 0 0
Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose
Timepoint [13] 0 0
0 to 24 hours post dose on Days 1 and 7
Secondary outcome [14] 0 0
Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire
Timepoint [14] 0 0
Baseline, Days 3, 5, 8, 14 and 21
Secondary outcome [15] 0 0
Duration of Signs and Symptoms of RSV Assessed by RI-PRO
Timepoint [15] 0 0
Baseline up to Day 21
Secondary outcome [16] 0 0
Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire
Timepoint [16] 0 0
Up to Day 21
Secondary outcome [17] 0 0
Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire
Timepoint [17] 0 0
Up to Day 21
Secondary outcome [18] 0 0
Predose Plasma Concentration (Ctrough) of JNJ-53718678
Timepoint [18] 0 0
Predose on Days 1 and 7
Secondary outcome [19] 0 0
Maximum Plasma Concentration (Cmax) of JNJ-53718678
Timepoint [19] 0 0
Days 1 and 7

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/12/2019
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Paratus Clinical Blacktown Clinic - Blacktown
Recruitment hospital [2] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment hospital [3] 0 0
Paratus Clinical Kanwal Clinic - Kanwal
Recruitment hospital [4] 0 0
Paratus Clinical Kippa Ring Clinic - Kippa Ring
Recruitment hospital [5] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [6] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2060 - Blacktown
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
2059 - Kanwal
Recruitment postcode(s) [4] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Montana
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
Argentina
State/province [10] 0 0
Bahia Blanca
Country [11] 0 0
Argentina
State/province [11] 0 0
Barrio Parque Velez Sarfield
Country [12] 0 0
Argentina
State/province [12] 0 0
Caba
Country [13] 0 0
Argentina
State/province [13] 0 0
Ciudad De La Plata
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudadela
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
General Roca
Country [17] 0 0
Argentina
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Rosario
Country [18] 0 0
Argentina
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San Miguel de Tucuman
Country [19] 0 0
Belgium
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Bruxelles
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Belgium
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Ham
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Belgium
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Massemen
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Belgium
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Tessenderlo
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Brazil
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Belo Horizonte
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Brazil
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Botucatu
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Brazil
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Florianopolis
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Brazil
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Natal
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Bulgaria
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Kozloduy
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Bulgaria
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Pernik
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Bulgaria
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Ruse
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Bulgaria
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Smolyan
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Bulgaria
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Sofia
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Bulgaria
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Troyan
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Canada
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Ontario
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Canada
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Quebec
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France
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Agen cedex 9
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France
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Angers
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France
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France
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Nantes
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France
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Paris
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Luebeck
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Japan
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Fukui-shi
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Kawasaki
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Kitakyusyu
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Koganei-Shi
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Kumamoto-shi
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Osaka
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Shinagawa-ku
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Japan
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Tokorozawa-shi
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Japan
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Toyota
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Japan
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Yukuhashi
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Korea, Republic of
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Bucheon
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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Aguascalientes
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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Monterrey
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Poland
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Kielce
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Poland
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Krakow
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Lodz
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Poland
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Ostrow Wielkopolski
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Poland
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Wroclaw
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Russian Federation
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Krasnogorsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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South Africa
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Johannesburg
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South Africa
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Pretoria
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South Africa
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Welkom
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Spain
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Alicante
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Spain
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Elche
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Spain
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Granada
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Spain
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Madrid
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Spain
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Santiago de Compostela
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Spain
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Vigo
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Sweden
State/province [85] 0 0
Malmö
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Sweden
State/province [86] 0 0
Umeå
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Sweden
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Uppsala
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Taiwan
State/province [88] 0 0
Kaohsiung
Country [89] 0 0
Taiwan
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New Taipei
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Taiwan
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Taichung City
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taipei City
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taipei
Country [93] 0 0
Ukraine
State/province [93] 0 0
Kharkiv
Country [94] 0 0
Ukraine
State/province [94] 0 0
Kherson
Country [95] 0 0
Ukraine
State/province [95] 0 0
Kyiv
Country [96] 0 0
Ukraine
State/province [96] 0 0
Vinnytsia
Country [97] 0 0
Ukraine
State/province [97] 0 0
Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03379675
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03379675