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Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.

Primary Purpose

Respiratory Syncytial Virus Infections

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Placebo

JNJ-53718678

About this trial

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

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Female participants must be of non-childbearing potential: postmenopausal for at least 2 years or surgically sterile or otherwise incapable of becoming pregnant
Female participants, except for postmenopausal women, must have a negative serum pregnancy test at screening
Participants must agree to comply with contraceptive measures as mentioned in protocol
Participants must be sero-suitable for respiratory syncytial virus (RSV) within 57 days prior to inoculation
Participants must be non-smokers for at least one month prior to screening and participants must have a negative cotinine test at screening

Exclusion Criteria:

Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome
Participants with a history or evidence of abuse of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 3 months, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures
Participants with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at screening
Participants with current hepatitis A infection, or hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening
Participants with active acute respiratory infection at admission (Study Day -1 or -2)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Participants will receive placebo or JNJ-53718678 500 milligram (mg) or 200 mg once daily for 7 days.

Participants will receive placebo or JNJ-53718678; dosing regimen in Cohort 2 will be decided based on Cohort 1 results.

Participants will receive placebo or JNJ-53718678, 75 mg once daily for 7 days.

Outcomes

Primary Outcome Measures

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

VL AUC for RSV-A Memphis 37b will be determined by quantitative reverse transcriptase -polymerase chain reaction (qRT-PCR) assay of nasal wash. The VL AUC will be calculated based on the viral load values measured 2 times per day, starting with the last value prior to first dosing, and ending with the last available value before discharge.

Secondary Outcome Measures

Area Under the Viral Load-time Curve (VL AUC) Determined by Plaque Forming Unit (PFU) Assay

VL AUC for RSV-A Memphis 37b will be determined by PFU assay of nasal wash.

Viral Load Over Time

Peak Viral Load

Time To Peak Viral Load

Time to peak viral load will be reported.

Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 24 Hours after First Dose

Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 48 Hours after First Dose

Time to Non-detectability of Virus

Time to non-detectability of virus from first administration of study drug will be assessed.

Total Clinical Symptom Score

Total clinical symptom score will be assessed using a composite of 10 self-reported symptoms on the Symptom Diary Card. The Investigator will review the participant's SDC entries on a daily basis after the administration of challenge virus inoculum. Total Clinical Symptom Score ranges from 0 (no symptoms) to 3 (not well).

Time to Peak Symptom Score After Viral Inoculation

Mucus Weight

Tissue Count

Sequence Analysis of the Rsv-A Memphis 37b Genome

Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry

FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.

Forced Vital Capacity (FVC) Measured by Spirometry

FVC is the total volume of air expired after a full inspiration.

FEV1/FVC Ratio

Full Information

NCT ID

NCT02387606

First Posted

March 9, 2015

Last Updated

October 25, 2022

Sponsor

Janssen Sciences Ireland UC

1. Study Identification

Unique Protocol Identification Number

NCT02387606

Brief Title

Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.

Official Title

A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

May 7, 2015 (Actual)

Primary Completion Date

September 21, 2015 (Actual)

Study Completion Date

October 2, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Sciences Ireland UC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the antiviral effect of repeated oral dosing of JNJ 53718678 compared to placebo in healthy adult participants infected through inoculation with respiratory syncytial virus (RSV)-A Memphis 37b virus.

Detailed Description

This is a randomized (study medication assigned to participants by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled, single-center study of JNJ 53718678 in healthy adult participants. Study consists of 3 phases: Screening (Day -56 and Study Day -3 prior to the planned date of virus inoculation/challenge on Study Day 0), quarantine (includes challenge on Day -1 or -2 and treatment for 7 days), and follow-up (Day 15 and 28). Participants will be admitted to the quarantine unit on Study Day -1 or - 2 and will be inoculated (intranasal) with the RSV-A Memphis 37b virus on Study Day 0. Participants will be evaluated in 3 cohorts: Cohort 1 and Cohort 3 (participants will be dosed with JNJ-53718678 or placebo for 7 days) and Cohort 2 (for up to 7 days [Dosing Days 1-x] [x will be determined based on the results from Cohort 1]). Participants will be randomized and JNJ-53718678/placebo dosing will be started after RSV presence in nasal wash has been detected by polymerase chain reaction (PCR). After completion of Cohort 1, data will be reviewed (unblinded) and the antiviral activity, safety, pharmacokinetic, clinical symptom and mucus weight data will be evaluated, based on which Cohort 2 will be initiated. 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

Keywords

Respiratory Syncytial Virus Infections, Placebo, Antiviral activity, JNJ-53718678

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Participants will receive placebo or JNJ-53718678 500 milligram (mg) or 200 mg once daily for 7 days.

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Participants will receive placebo or JNJ-53718678; dosing regimen in Cohort 2 will be decided based on Cohort 1 results.

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Participants will receive placebo or JNJ-53718678, 75 mg once daily for 7 days.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive placebo once daily.

Intervention Type

Drug

Intervention Name(s)

JNJ-53718678

Intervention Description

Participants will receive JNJ-53718678 as 20 milliliter (mL) (200 mg) or 50 mL (500 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 1. JNJ-53718678 dose in Cohort 2 will be decided based on Cohort 1 results. JNJ-53718678 as 7.5 mL (75 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 3.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

up to Follow-up (Day 28)

Secondary Outcome Measure Information:

Title

Area Under the Viral Load-time Curve (VL AUC) Determined by Plaque Forming Unit (PFU) Assay

Description

VL AUC for RSV-A Memphis 37b will be determined by PFU assay of nasal wash.

Time Frame

Baseline up to Follow-up (Day 28)

Title

Viral Load Over Time

Time Frame

Baseline up to Follow-up (Day 28)

Title

Peak Viral Load

Time Frame

Baseline up to Follow-up (Day 28)

Title

Time To Peak Viral Load

Description

Time to peak viral load will be reported.

Time Frame

Baseline up to Follow-up (Day 28)

Title

Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 24 Hours after First Dose

Time Frame

24 hours after first dose

Title

Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 48 Hours after First Dose

Time Frame

48 hours after first dose

Title

Time to Non-detectability of Virus

Description

Time to non-detectability of virus from first administration of study drug will be assessed.

Time Frame

Baseline up to Follow-up (Day 28)

Title

Total Clinical Symptom Score

Description

Time Frame

Admission (Day -1 or -2) up to Day 13

Title

Time to Peak Symptom Score After Viral Inoculation

Time Frame

Admission (Day -1 or -2) up to Day 13

Title

Mucus Weight

Time Frame

Baseline up to Day 13

Title

Tissue Count

Time Frame

Baseline up to Day 13

Title

Sequence Analysis of the Rsv-A Memphis 37b Genome

Time Frame

Baseline and post-Baseline

Title

Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry

Description

FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.

Time Frame

Baseline up to Follow-up (Day 28)

Title

Forced Vital Capacity (FVC) Measured by Spirometry

Description

FVC is the total volume of air expired after a full inspiration.

Time Frame

Baseline up to Follow-up (Day 28)

Title

FEV1/FVC Ratio

Time Frame

Baseline up to Follow-up (Day 28)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female participants must be of non-childbearing potential: postmenopausal for at least 2 years or surgically sterile or otherwise incapable of becoming pregnant Female participants, except for postmenopausal women, must have a negative serum pregnancy test at screening Participants must agree to comply with contraceptive measures as mentioned in protocol Participants must be sero-suitable for respiratory syncytial virus (RSV) within 57 days prior to inoculation Participants must be non-smokers for at least one month prior to screening and participants must have a negative cotinine test at screening Exclusion Criteria: Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome Participants with a history or evidence of abuse of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 3 months, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures Participants with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at screening Participants with current hepatitis A infection, or hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening Participants with active acute respiratory infection at admission (Study Day -1 or -2)

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

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29684148

Citation

Stevens M, Rusch S, DeVincenzo J, Kim YI, Harrison L, Meals EA, Boyers A, Fok-Seang J, Huntjens D, Lounis N, Mari N K, Remmerie B, Roymans D, Koul A, Verloes R. Antiviral Activity of Oral JNJ-53718678 in Healthy Adult Volunteers Challenged With Respiratory Syncytial Virus: A Placebo-Controlled Study. J Infect Dis. 2018 Jul 24;218(5):748-756. doi: 10.1093/infdis/jiy227.

Results Reference

derived

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Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.

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