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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02593851




Registration number
NCT02593851
Ethics application status
Date submitted
21/08/2015
Date registered
1/11/2015
Date last updated
6/12/2019

Titles & IDs
Public title
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection
Scientific title
A Phase 1b, Randomized, Partially Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With RSV Infection
Secondary ID [1] 0 0
2015-002003-28
Secondary ID [2] 0 0
CR107945
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Part 1: Cohort 1a - Participants (greater than or equal to [>=] 6 months and less than or equal to [<=] 24 months of age) will receive JNJ-53718678, 2 milligram per kilogram body weight (mg/kg) oral solution once daily on Day 1 to Day 7. Dose and/or dosing regimen may be adapted in subsequent cohorts based on the review of the safety/tolerability and full pharmacokinetic data from Cohort 1a.

Experimental: Part 1: Cohort 1b - Participants (>= 6 months and <= 24 months of age) will receive total daily dose of 6 mg/kg JNJ-53718678 oral solution or placebo [either in once daily [qd] or twice daily [bid]) on Day 1 to Day 7.

Experimental: Part 1: Cohort 1c - Participants (>= 6 months and <= 24 months of age) will receive total daily dose of 18 mg/kg JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7.

Experimental: Part 1: Cohort 1d - Participants (>= 6 months and <= 24 months of age) will receive JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7. The cohort 1d is optional and may be included at the discretion of the sponsor.

Experimental: Part 1: Cohort 1e - Participants (>= 6 months and <= 24 months of age) will receive JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7. The cohort 1e is optional and may be included at the discretion of the sponsor.

Experimental: Part 1: Cohort 2a - Participants (>= 3 months and less than [<] 6 months of age) will receive total daily dose of 1.5 mg/kg JNJ-53718678 oral solution [either in a qd or a bid regimen] on Day 1 to Day 7.

Experimental: Part 1: Cohort 2b - Participants (>=3 months and < 6 months of age) will receive total daily dose of 4.5 mg/kg JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7.

Experimental: Part 1: Cohort 2c - Participants (>= 3 months and < 6 months of age) will receive total daily dose of 13.5 mg/kg JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7

Experimental: Part 1: Cohort 2d - Participants (>= 3 months and < 6 months of age) will receive JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7. The cohort 2d is optional and may be included at the discretion of the sponsor.

Experimental: Part 1: Cohort 2e - Participants (>= 3 months and < 6 months of age) will receive JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7. The cohort 2e is optional and may be included at the discretion of the sponsor.

Experimental: Part 1: Cohort 3a - Participants (greater than (>) 1 month and < 3 months of age) will receive total daily dose of 1 mg/kg JNJ-53718678 oral solution [either in a qd or a bid regimen] on Day 1 to Day 7.

Experimental: Part 1: Cohort 3b - Participants (> 1 month and < 3 months of age) will receive total daily dose of 3 mg/kg JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7.

Experimental: Part 1: Cohort 3c - Participants (> 1 month and < 3 months of age) will receive total daily dose of 9 mg/kg JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7.

Experimental: Part 1: Cohort 3d - Participants (> 1 month and < 3 months of age) will receive JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7. The cohort 3d is optional and may be included at the discretion of the sponsor.

Experimental: Part 1: Cohort 3e - Participants (> 1 month and < 3 months of age) will receive JNJ-53718678 oral solution or placebo [either in a qd or a bid regimen] on Day 1 to Day 7. The cohort 3e is optional and may be included at the discretion of the sponsor.

Experimental: Part 2: Cohort f - Participants of all age groups will receive daily dose of JNJ-53718678 oral solution or placebo, either in a qd or a bid regimen on Days 1 to 7.


Treatment: Drugs: JNJ-53718678
JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Treatment: Drugs: Placebo
Placebo oral solution will be administered once or twice daily for 7 days.

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

Outcomes
Primary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 - The Cmax is the maximum observed plasma concentration.
Timepoint [1] 0 0
Days 1, 2 and 3
Primary outcome [2] 0 0
Trough Plasma Concentration (Ctrough) of JNJ-53718678 - The Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
Timepoint [2] 0 0
Days 1, 2 and 3
Primary outcome [3] 0 0
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) - The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval.
Timepoint [3] 0 0
Days 1, 2 and 3
Primary outcome [4] 0 0
Total Apparent Clearance (CL/F) of JNJ-53718678 - Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Timepoint [4] 0 0
Days 1, 2 and 3
Primary outcome [5] 0 0
Apparent Volume of Distribution (Vd/F) of JNJ-53718678 - Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vd/F) is influenced by the fraction absorbed.
Timepoint [5] 0 0
Days 1, 2 and 3
Primary outcome [6] 0 0
Number of Participants With Adverse Events - 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.
Timepoint [6] 0 0
Up to Follow-up (Day 28)
Secondary outcome [1] 0 0
Area Under the Viral Load-time Curve (VL AUC) - VL will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs. The VL AUC (copies. hour/ml) will be calculated based on the trapezoidal method.
Timepoint [1] 0 0
Up to Follow-up (Day 28)
Secondary outcome [2] 0 0
Amount of Viral Load Over Time - VL (copies/ml) at each assessment timepoint where a nasal sample is obtained.
Timepoint [2] 0 0
Up to Follow-up (Day 28)
Secondary outcome [3] 0 0
Number of viral particles at Peak Viral Load - Peak viral load (copies/ml) is a measure of the maximum number of viral particles present in nasal swabs.
Timepoint [3] 0 0
Up to Follow-up (Day 28)
Secondary outcome [4] 0 0
Time To Peak Viral Load - Time (hours) to peak viral load will be reported.
Timepoint [4] 0 0
Up to Follow-up (Day 28)
Secondary outcome [5] 0 0
Number of Participants Reaching Undetectability of virus Between First Administration of Study Drug and Day 28 - Non-detectability of virus in nasal swabs between first administration of study drug and Day 28 will be reported.
Timepoint [5] 0 0
Day 1 to Day 28
Secondary outcome [6] 0 0
Total Number of Respiratory Syncytial Virus (RSV) Hospitalization Days from Admission to Discharge - The total number of Respiratory Syncytial Virus (RSV) hospitalization days from admission to discharge will be reported.
Timepoint [6] 0 0
Up to Follow-up (Day 28)
Secondary outcome [7] 0 0
Total RSV Hospitalization Days with Supplemental Oxygen Requirement - The total number of RSV Hospitalization Days with Supplemental Oxygen Requirement will be reported.
Timepoint [7] 0 0
Up to Follow-up (Day 28)
Secondary outcome [8] 0 0
The Number of days in Intensive care unit (ICU) due to RSV - The number of days stayed in ICU due to RSV will be reported.
Timepoint [8] 0 0
Up to Follow-up (Day 28)
Secondary outcome [9] 0 0
Total Days of non-invasive ventilator support During RSV Hospitalization - The total number of days with non-invasive ventilator support during RSV hospitalization will be reported.
Timepoint [9] 0 0
Up to Follow-up (Day 28)
Secondary outcome [10] 0 0
Total Days of Mechanical Ventilation During RSV Hospitalization - The total number of days with Mechanical Ventilation during RSV hospitalization will be reported.
Timepoint [10] 0 0
Up to Follow-up (Day 28)
Secondary outcome [11] 0 0
Changes in Peripheral Capillary Oxygen Saturation (SpO2) - The Percentage of Peripheral Capillary Oxygen Saturation (SpO2) will be assessed by the investigator during hospitalisation.
Timepoint [11] 0 0
Up to Follow-up (Day 28)
Secondary outcome [12] 0 0
Change from Baseline in Respiratory Rate - The Respiratory rate (number of breaths per minute) will be assessed by the investigator and caregiver during hospitalisation.
Timepoint [12] 0 0
Up to Follow-up (Day 28)
Secondary outcome [13] 0 0
Change from Baseline in Body Temperature - The body temperature (degrees Celcius) will be assessed by the investigator and caregiver during hospitalisation.
Timepoint [13] 0 0
Up to Follow-up (Day 28)
Secondary outcome [14] 0 0
Clinical Symptom Score - The clinical symptom score will be assessed by the investigator (Clinician Outcome Assessment) and caregiver symptom Diary for each symptom. Clinical Symptom score ranges from 0 (best) to 4 (worst).
Timepoint [14] 0 0
Up to Follow-up (Day 28)

Eligibility
Key inclusion criteria
- Participant has presented at the hospital for suspected Respiratory Syncytial Virus
(RSV) infection within 72 hours prior to Screening completion

- Participant has been hospitalized for this suspected RSV infection

- Participant has been diagnosed with RSV infection using a polymerase chain reaction
(PCR)-based assay, preferably commercially available locally

- Participant was born after a normal term pregnancy (greater than or equal to 37 weeks
and 0 days)

- A legally acceptable representative of the participant must sign an Informed consent
form (ICF) indicating that he or she understands the purpose of and procedures
required for the study, are willing for their child to participate in the study, are
willing for their child to remain in the hospital for the first 3 days of dosing (even
if not clinically indicated), and are willing/able to adhere to the prohibitions and
restrictions specified in the protocol and study procedures
Minimum age
1 Month
Maximum age
24 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant who had major surgery within the 28 days prior to randomization or planned
major surgery through the course of the study

- Participant has major congenital anomalies or known cytogenetic disorders

- Participant has known or suspected immunodeficiency, such as known human
immunodeficiency virus (HIV) infection

- Participant has known or suspected hepatitis B or C infection

- Participant is upon current admission initially hospitalized in the Intensive care
unit (ICU) and/or in need of invasive endotracheal mechanical ventilation

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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Geelong
Recruitment hospital [2] 0 0
- Hobart
Recruitment hospital [3] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Geelong
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
Argentina
State/province [2] 0 0
Bahía Blanca
Country [3] 0 0
Argentina
State/province [3] 0 0
City of Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Córdoba
Country [5] 0 0
Belgium
State/province [5] 0 0
Anderlecht
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Charleroi
Country [8] 0 0
Belgium
State/province [8] 0 0
Edegem
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Belgium
State/province [10] 0 0
Lier
Country [11] 0 0
Brazil
State/province [11] 0 0
Curitiba
Country [12] 0 0
Brazil
State/province [12] 0 0
Porto Alegre
Country [13] 0 0
Brazil
State/province [13] 0 0
Ribeirao Preto
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio de Janeiro
Country [15] 0 0
Brazil
State/province [15] 0 0
São Paulo
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Germany
State/province [17] 0 0
Hamm
Country [18] 0 0
Germany
State/province [18] 0 0
Heidelberg
Country [19] 0 0
Germany
State/province [19] 0 0
München
Country [20] 0 0
Netherlands
State/province [20] 0 0
Hoofddorp
Country [21] 0 0
Netherlands
State/province [21] 0 0
Utrecht
Country [22] 0 0
Philippines
State/province [22] 0 0
Cebu City
Country [23] 0 0
Philippines
State/province [23] 0 0
Manila City
Country [24] 0 0
Spain
State/province [24] 0 0
Almeria
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Spain
State/province [26] 0 0
Esplugues de Llobregat
Country [27] 0 0
Spain
State/province [27] 0 0
Getafe
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Malaga
Country [30] 0 0
Spain
State/province [30] 0 0
Santiago de Compostela
Country [31] 0 0
Spain
State/province [31] 0 0
Sevilla
Country [32] 0 0
Spain
State/province [32] 0 0
Valencia
Country [33] 0 0
Sweden
State/province [33] 0 0
Göteborg
Country [34] 0 0
Sweden
State/province [34] 0 0
Linköping
Country [35] 0 0
Sweden
State/province [35] 0 0
Lund
Country [36] 0 0
Sweden
State/province [36] 0 0
Malmö

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Sciences Ireland UC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral
activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection
after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in
infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are
hospitalized with RSV infection.
Trial website
https://clinicaltrials.gov/show/NCT02593851
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Sciences Ireland UC Clinical Trial
Address 0 0
Janssen Sciences Ireland UC
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/show/NCT02593851