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

Janssen (J&J Innovative Medicine)

Status and phase

Terminated

Phase 1

Conditions

Respiratory Syncytial Virus Infections

Virus Diseases

Treatments

Drug: JNJ-53718678

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02593851

53718678RSV1005 (Other Identifier)

CR107945

2015-002003-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

1 to 24 months old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 16 patient groups

Part 1: Cohort 1a

Experimental group

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.

Treatment:

Drug: JNJ-53718678

Part 1: Cohort 1b

Experimental group

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 1c

Experimental group

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 1d

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 1e

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 2a

Experimental group

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.

Treatment:

Drug: JNJ-53718678

Part 1: Cohort 2b

Experimental group

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 2c

Experimental group

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

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 2d

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 2e

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 3a

Experimental group

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.

Treatment:

Drug: JNJ-53718678

Part 1: Cohort 3b

Experimental group

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 3c

Experimental group

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 3d

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 1: Cohort 3e

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678

Part 2: Cohort f

Experimental group

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.

Treatment:

Drug: Placebo

Drug: JNJ-53718678