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Respiratory Syncytial Virus InfectionsPhase 1NCT02593851

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

A Phase 1 study testing JNJ-53718678 in people with Respiratory Syncytial Virus Infections and Virus Diseases, run by Janssen Sciences Ireland UC at 39 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 month to 24 months
What is being tested?
JNJ-53718678
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
39 sitesin 10 countries
Study dates
4 Dec 2015to 10 Nov 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

39 sites in 10 countries.

39 sites in 10 countries

Spain9 sites

  • Study site

    Almería

  • Study site

    Barcelona

  • Study site

    Esplugues de Llobregat

  • Study site

    Getafe

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Santiago de Compostela

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

Belgium6 sites

  • Study site

    Anderlecht

  • Study site

    Brussels

  • Study site

    Charleroi

  • Study site

    Edegem

  • Study site

    Leuven

  • Study site

    Lier

Other trials in Belgium

Brazil5 sites

  • Study site

    Curitiba

  • Study site

    Porto Alegre

  • Study site

    Ribeirão Preto

  • Study site

    Rio de Janeiro

  • Study site

    São Paulo

Other trials in Brazil

Germany4 sites

  • Study site

    Freiburg im Breisgau

  • Study site

    Hamm

  • Study site

    Heidelberg

  • Study site

    München

Other trials in Germany

Sweden4 sites

  • Study site

    Gothenburg

  • Study site

    Linköping

  • Study site

    Lund

  • Study site

    Malmö

Other trials in Sweden

Argentina3 sites

  • Study site

    Bahía Blanca

  • Study site

    City of Buenos Aires

  • Study site

    Córdoba

Other trials in Argentina

Australia3 sites

  • Study site

    Geelong

  • Study site

    Hobart

  • Study site

    Westmead

Other trials in Australia

Netherlands2 sites

  • Study site

    Hoofddorp

  • Study site

    Utrecht

Other trials in Netherlands

Philippines2 sites

  • Study site

    Cebu City

  • Study site

    Manila

Other trials in Philippines

United States1 site

  • Study site

    Kirksville, Missouri

Other trials in United States

About this study

Official 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

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.

Read the detailed description

This is a Phase 1b, randomized (study medication assigned to participants by chance), partially double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled, multicenter, multiple ascending dose study of JNJ 53718678 in infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are hospitalized with RSV infection. The duration of study will be approximately 4 weeks for each participant excluding screening period. In Part 1 of study, minimum total number of 42 participants will be divided in 3 cohorts: Age group 1 (Cohorts 1a-1e) (greater than or equal to [>=] 6 months and less than or equal to [<=] 24 months of age), Age group 2 (Cohorts 2a-2e)(>=3 months and less than [<] 6 months of age) and Age group 3 (Cohorts 3a-3e) (greater than [>] 1 month and <3 months of age). Each age group will consist of a minimum of 3 cohorts with the possibility to add 2 more per age group (Cohorts a through e) in which different doses and/or dosing regimens will be evaluated. Each cohort will consist of 5 participants (4 participants receiving JNJ-53718678 and 1 participant receiving placebo for 7 days), except for the first cohort of each age group which will contain only 4 participants (4 participants receiving JNJ 53718678). In Part 2 of the study, all age groups will be included in a single cohort, Cohort f, in which the selected dose regimen determined during Part 1 of the study will be used for each of the 3 age groups. A minimum of approximately 18 (12 participants receiving JNJ 53718678 and 6 participants receiving placebo) and a maximum of 24 participants (16 participants receiving JNJ 53718678 and 8 participants receiving placebo) will be included in this part of the study. Pharmacokinetics and safety of JNJ-53718678 will be evaluated primarily. Participants' safety will be monitored throughout the study.

Being tested
JNJ-53718678, Placebo
Keywords
Respiratory Syncytial Virus Infections, JNJ-53718678, Placebo, Infants
Medical subject headings
Respiratory Syncytial Virus Infections, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-53718678Drug

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

  • PlaceboDrug

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

Study groups in NCT02593851
Study groupRoleWhat they receive
Part 1: Cohort 1aExperimentalParticipants (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.
Receives: Drug: JNJ-53718678
Part 1: Cohort 1bExperimentalParticipants (>= 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 1cExperimentalParticipants (>= 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 1dExperimentalParticipants (>= 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 1eExperimentalParticipants (>= 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 2aExperimentalParticipants (>= 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.
Receives: Drug: JNJ-53718678
Part 1: Cohort 2bExperimentalParticipants (>=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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 2cExperimentalParticipants (>= 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
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 2dExperimentalParticipants (>= 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 2eExperimentalParticipants (>= 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 3aExperimentalParticipants (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.
Receives: Drug: JNJ-53718678
Part 1: Cohort 3bExperimentalParticipants (> 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 3cExperimentalParticipants (> 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 3dExperimentalParticipants (> 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 1: Cohort 3eExperimentalParticipants (> 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.
Receives: Drug: JNJ-53718678; Drug: Placebo
Part 2: Cohort fExperimentalParticipants 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.
Receives: Drug: JNJ-53718678; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678

    The Cmax is the maximum observed plasma concentration.

    Measured: Days 1, 2 and 3

  2. 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.

    Measured: Days 1, 2 and 3

  3. 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.

    Measured: Days 1, 2 and 3

  4. 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.

    Measured: Days 1, 2 and 3

  5. 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.

    Measured: Days 1, 2 and 3

  6. 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.

    Measured: Up to Follow-up (Day 28)

Secondary outcomes (14)

  1. 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.

    Measured: Up to Follow-up (Day 28)

  2. Amount of Viral Load Over Time

    VL (copies/ml) at each assessment timepoint where a nasal sample is obtained.

    Measured: Up to Follow-up (Day 28)

  3. 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.

    Measured: Up to Follow-up (Day 28)

  4. Time To Peak Viral Load

    Time (hours) to peak viral load will be reported.

    Measured: Up to Follow-up (Day 28)

  5. 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.

    Measured: Day 1 to Day 28

  6. 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.

    Measured: Up to Follow-up (Day 28)

  7. Total RSV Hospitalization Days with Supplemental Oxygen Requirement

    The total number of RSV Hospitalization Days with Supplemental Oxygen Requirement will be reported.

    Measured: Up to Follow-up (Day 28)

  8. 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.

    Measured: Up to Follow-up (Day 28)

  9. 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.

    Measured: Up to Follow-up (Day 28)

  10. Total Days of Mechanical Ventilation During RSV Hospitalization

    The total number of days with Mechanical Ventilation during RSV hospitalization will be reported.

    Measured: Up to Follow-up (Day 28)

  11. Changes in Peripheral Capillary Oxygen Saturation (SpO2)

    The Percentage of Peripheral Capillary Oxygen Saturation (SpO2) will be assessed by the investigator during hospitalisation.

    Measured: Up to Follow-up (Day 28)

  12. Change from Baseline in Respiratory Rate

    The Respiratory rate (number of breaths per minute) will be assessed by the investigator and caregiver during hospitalisation.

    Measured: Up to Follow-up (Day 28)

  13. Change from Baseline in Body Temperature

    The body temperature (degrees Celcius) will be assessed by the investigator and caregiver during hospitalisation.

    Measured: Up to Follow-up (Day 28)

  14. 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).

    Measured: Up to Follow-up (Day 28)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2015 (estimated)
  2. Study start4 Dec 2015
  3. Primary completion21 Mar 2017
  4. Study completion10 Nov 2017

Why it stopped: Trial was cancelled due to availability of clinical supplies.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02593851
Sponsor's protocol ID
CR107945
Other IDs
2015-002003-28, 53718678RSV1005, 2015
Status last verified
Dec 2019
First submitted
21 Aug 2015
Last updated
6 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes

Publications

  • Martinon-Torres F, Rusch S, Huntjens D, Remmerie B, Vingerhoets J, McFadyen K, Ferrero F, Baraldi E, Rojo P, Epalza C, Stevens M. Pharmacokinetics, Safety, and Antiviral Effects of Multiple Doses of the Respiratory Syncytial Virus (RSV) Fusion Protein Inhibitor, JNJ-53718678, in Infants Hospitalized With RSV Infection: A Randomized Phase 1b Study. Clin Infect Dis. 2020 Dec 17;71(10):e594-e603. doi: 10.1093/cid/ciaa283.

    PubMed 32201897

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-53718678 in people with Respiratory Syncytial Virus Infections and Virus Diseases, run by Janssen Sciences Ireland UC at 39 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Spain, Belgium, Brazil, Germany, Sweden and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Trial was cancelled due to availability of clinical supplies.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 (time frame: Days 1, 2 and 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02593851, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.

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