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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

Primary Purpose

Respiratory Syncytial Virus Infections, Virus Diseases

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

JNJ-53718678

Placebo

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory Syncytial Virus Infections, JNJ-53718678, Placebo, Infants

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Arm Label

Part 1: Cohort 1a

Part 1: Cohort 1b

Part 1: Cohort 1c

Part 1: Cohort 1d

Part 1: Cohort 1e

Part 1: Cohort 2a

Part 1: Cohort 2b

Part 1: Cohort 2c

Part 1: Cohort 2d

Part 1: Cohort 2e

Part 1: Cohort 3a

Part 1: Cohort 3b

Part 1: Cohort 3c

Part 1: Cohort 3d

Part 1: Cohort 3e

Part 2: Cohort f

Arm Description

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678

The Cmax is the maximum observed plasma concentration.

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.

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.

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.

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.

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.

Secondary Outcome Measures

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.

Amount of Viral Load Over Time

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

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.

Time To Peak Viral Load

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

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.

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.

Total RSV Hospitalization Days with Supplemental Oxygen Requirement

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

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.

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.

Total Days of Mechanical Ventilation During RSV Hospitalization

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

Changes in Peripheral Capillary Oxygen Saturation (SpO2)

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

Change from Baseline in Respiratory Rate

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

Change from Baseline in Body Temperature

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

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).

Full Information

NCT ID

NCT02593851

First Posted

August 21, 2015

Last Updated

December 5, 2019

Sponsor

Janssen Sciences Ireland UC

1. Study Identification

Unique Protocol Identification Number

NCT02593851

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Terminated

Why Stopped

Trial was cancelled due to availability of clinical supplies.

Study Start Date

December 4, 2015 (Actual)

Primary Completion Date

March 21, 2017 (Actual)

Study Completion Date

November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Sciences Ireland UC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Syncytial Virus Infections, Virus Diseases

Keywords

Respiratory Syncytial Virus Infections, JNJ-53718678, Placebo, Infants

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Cohort 1a

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Cohort 1b

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: Cohort 1c

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: Cohort 1d

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Cohort 1e

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Cohort 2a

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: Cohort 2b

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: Cohort 2c

Arm Type

Experimental

Arm Description

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

Arm Title

Part 1: Cohort 2d

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Cohort 2e

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Cohort 3a

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: Cohort 3b

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: Cohort 3c

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: Cohort 3d

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Cohort 3e

Arm Type

Experimental

Arm Description

Arm Title

Part 2: Cohort f

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

JNJ-53718678

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678

Description

The Cmax is the maximum observed plasma concentration.

Time Frame

Days 1, 2 and 3

Title

Trough Plasma Concentration (Ctrough) of JNJ-53718678

Description

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.

Time Frame

Days 1, 2 and 3

Title

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

Description

The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval.

Time Frame

Days 1, 2 and 3

Title

Total Apparent Clearance (CL/F) of JNJ-53718678

Description

Time Frame

Days 1, 2 and 3

Title

Apparent Volume of Distribution (Vd/F) of JNJ-53718678

Description

Time Frame

Days 1, 2 and 3

Title

Number of Participants With Adverse Events

Description

Time Frame

Up to Follow-up (Day 28)

Secondary Outcome Measure Information:

Title

Area Under the Viral Load-time Curve (VL AUC)

Description

Time Frame

Up to Follow-up (Day 28)

Title

Amount of Viral Load Over Time

Description

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

Time Frame

Up to Follow-up (Day 28)

Title

Number of viral particles at Peak Viral Load

Description

Peak viral load (copies/ml) is a measure of the maximum number of viral particles present in nasal swabs.

Time Frame

Up to Follow-up (Day 28)

Title

Time To Peak Viral Load

Description

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

Time Frame

Up to Follow-up (Day 28)

Title

Number of Participants Reaching Undetectability of virus Between First Administration of Study Drug and Day 28

Description

Non-detectability of virus in nasal swabs between first administration of study drug and Day 28 will be reported.

Time Frame

Day 1 to Day 28

Title

Total Number of Respiratory Syncytial Virus (RSV) Hospitalization Days from Admission to Discharge

Description

The total number of Respiratory Syncytial Virus (RSV) hospitalization days from admission to discharge will be reported.

Time Frame

Up to Follow-up (Day 28)

Title

Total RSV Hospitalization Days with Supplemental Oxygen Requirement

Description

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

Time Frame

Up to Follow-up (Day 28)

Title

The Number of days in Intensive care unit (ICU) due to RSV

Description

The number of days stayed in ICU due to RSV will be reported.

Time Frame

Up to Follow-up (Day 28)

Title

Total Days of non-invasive ventilator support During RSV Hospitalization

Description

The total number of days with non-invasive ventilator support during RSV hospitalization will be reported.

Time Frame

Up to Follow-up (Day 28)

Title

Total Days of Mechanical Ventilation During RSV Hospitalization

Description

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

Time Frame

Up to Follow-up (Day 28)

Title

Changes in Peripheral Capillary Oxygen Saturation (SpO2)

Description

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

Time Frame

Up to Follow-up (Day 28)

Title

Change from Baseline in Respiratory Rate

Description

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

Time Frame

Up to Follow-up (Day 28)

Title

Change from Baseline in Body Temperature

Description

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

Time Frame

Up to Follow-up (Day 28)

Title

Clinical Symptom Score

Description

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).

Time Frame

Up to Follow-up (Day 28)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Sciences Ireland UC Clinical Trial

Organizational Affiliation

Janssen Sciences Ireland UC

Official's Role

Study Director

Facility Information:

City

Kirksville

State/Province

Missouri

Country

United States

City

Bahía Blanca

Country

Argentina

City

City of Buenos Aires

Country

Argentina

City

Córdoba

Country

Argentina

City

Geelong

Country

Australia

City

Hobart

Country

Australia

City

Westmead

Country

Australia

City

Anderlecht

Country

Belgium

City

Bruxelles

Country

Belgium

City

Charleroi

Country

Belgium

City

Edegem

Country

Belgium

City

Leuven

Country

Belgium

City

Lier

Country

Belgium

City

Curitiba

Country

Brazil

City

Porto Alegre

Country

Brazil

City

Ribeirao Preto

Country

Brazil

City

Rio de Janeiro

Country

Brazil

City

São Paulo

Country

Brazil

City

Freiburg

Country

Germany

City

Hamm

Country

Germany

City

Heidelberg

Country

Germany

City

München

Country

Germany

City

Hoofddorp

Country

Netherlands

City

Utrecht

Country

Netherlands

City

Cebu City

Country

Philippines

City

Manila City

Country

Philippines

City

Almeria

Country

Spain

City

Barcelona

Country

Spain

City

Esplugues de Llobregat

Country

Spain

City

Getafe

Country

Spain

City

Madrid

Country

Spain

City

Malaga

Country

Spain

City

Santiago de Compostela

Country

Spain

City

Sevilla

Country

Spain

City

Valencia

Country

Spain

City

Göteborg

Country

Sweden

City

Linköping

Country

Sweden

City

Lund

Country

Sweden

City

Malmö

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

32201897

Citation

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.

Results Reference

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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

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