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AzTrials

Respiratory Syncytial Virus InfectionsPhase 2NCT02387606

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

A Phase 2 study testing JNJ-53718678 in people with Respiratory Syncytial Virus Infections, run by Janssen Sciences Ireland UC at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
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
66 participants
Where
1 siteUnited Kingdom
Study dates
7 May 2015to 2 Oct 2015
Phase
Phase 2
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Study site

    London

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Placebo, JNJ-53718678
Keywords
Respiratory Syncytial Virus Infections, Placebo, Antiviral activity, JNJ-53718678
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

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

  • PlaceboDrug

    Participants will receive placebo once daily.

  • JNJ-53718678Drug

    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.

Study groups in NCT02387606
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants will receive placebo or JNJ-53718678 500 milligram (mg) or 200 mg once daily for 7 days.
Receives: Drug: Placebo; Drug: JNJ-53718678
Cohort 2ExperimentalParticipants will receive placebo or JNJ-53718678; dosing regimen in Cohort 2 will be decided based on Cohort 1 results.
Receives: Drug: Placebo; Drug: JNJ-53718678
Cohort 3ExperimentalParticipants will receive placebo or JNJ-53718678, 75 mg once daily for 7 days.
Receives: Drug: Placebo; Drug: JNJ-53718678

What is being measured

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

  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.

    Measured: up to Follow-up (Day 28)

Secondary outcomes (15)

  1. 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.

    Measured: Baseline up to Follow-up (Day 28)

  2. Viral Load Over Time

    Measured: Baseline up to Follow-up (Day 28)

  3. Peak Viral Load

    Measured: Baseline up to Follow-up (Day 28)

  4. Time To Peak Viral Load

    Time to peak viral load will be reported.

    Measured: Baseline up to Follow-up (Day 28)

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

    Measured: 24 hours after first dose

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

    Measured: 48 hours after first dose

  7. Time to Non-detectability of Virus

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

    Measured: Baseline up to Follow-up (Day 28)

  8. 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).

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

  9. Time to Peak Symptom Score After Viral Inoculation

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

  10. Mucus Weight

    Measured: Baseline up to Day 13

  11. Tissue Count

    Measured: Baseline up to Day 13

  12. Sequence Analysis of the Rsv-A Memphis 37b Genome

    Measured: Baseline and post-Baseline

  13. 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.

    Measured: Baseline up to Follow-up (Day 28)

  14. Forced Vital Capacity (FVC) Measured by Spirometry

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

    Measured: Baseline up to Follow-up (Day 28)

  15. FEV1/FVC Ratio

    Measured: Baseline 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 posted13 Mar 2015 (estimated)
  2. Study start7 May 2015
  3. Primary completion21 Sep 2015
  4. Study completion2 Oct 2015

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02387606
Sponsor's protocol ID
CR106786
Other IDs
2014-005041-41, 53718678RSV2001, 2014
Status last verified
Oct 2022
First submitted
9 Mar 2015
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29684148

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-53718678 in people with Respiratory Syncytial Virus Infections, run by Janssen Sciences Ireland UC at 1 site in United Kingdom.

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: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area Under the Viral Load-time Curve (VL AUC) (time frame: up to Follow-up (Day 28)). 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 NCT02387606, 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 26 Oct 2022.

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