Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.
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
3 other identifiers
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedStudy Start
First participant enrolled
May 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2015
CompletedOctober 26, 2022
October 1, 2022
5 months
March 9, 2015
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to Follow-up (Day 28)
Secondary Outcomes (15)
Area Under the Viral Load-time Curve (VL AUC) Determined by Plaque Forming Unit (PFU) Assay
Baseline up to Follow-up (Day 28)
Viral Load Over Time
Baseline up to Follow-up (Day 28)
Peak Viral Load
Baseline up to Follow-up (Day 28)
Time To Peak Viral Load
Baseline up to Follow-up (Day 28)
Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 24 Hours after First Dose
24 hours after first dose
- +10 more secondary outcomes
Study Arms (3)
Cohort 1
EXPERIMENTALParticipants will receive placebo or JNJ-53718678 500 milligram (mg) or 200 mg once daily for 7 days.
Cohort 2
EXPERIMENTALParticipants will receive placebo or JNJ-53718678; dosing regimen in Cohort 2 will be decided based on Cohort 1 results.
Cohort 3
EXPERIMENTALParticipants will receive placebo or JNJ-53718678, 75 mg once daily for 7 days.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
London, United Kingdom
Related Publications (1)
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.
PMID: 29684148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Sciences Ireland UC Clinical Trial
Janssen Sciences Ireland UC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2015
First Posted
March 13, 2015
Study Start
May 7, 2015
Primary Completion
September 21, 2015
Study Completion
October 2, 2015
Last Updated
October 26, 2022
Record last verified: 2022-10