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NCT02593851 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Janssen Sciences Ireland UC.

Terminated
Registry status
Phase 1
Development phase
45
Enrollment target

NCT02593851: Clinical Trial Phase 1 study, sponsored by Janssen Sciences Ireland UC.

NCT02593851 is a Phase 1 study that was terminated before completion, run by Janssen Sciences Ireland UC. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02593851, a Phase 1 study, was terminated before completion, sponsored by Janssen Sciences Ireland UC.

TERMINATED
Registry status
Phase 1
Development phase
45 participants
Enrollment target

Study 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.

Primary Outcome

The Cmax is the maximum observed plasma concentration.

Interventions

  • DRUG Placebo
  • DRUG JNJ-53718678

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2015-12-04
Est. Completion 2017-11-10
Phase Phase 1
Janssen Sciences Ireland UC

7 total trials

Why NCT02593851 stopped before completion

NCT02593851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02593851 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02593851 about?

NCT02593851 is a clinical study titled "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". 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 ...

What is the current status of trial NCT02593851?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2015-12-04. Estimated completion is 2017-11-10.

What interventions are being tested in trial NCT02593851?

The interventions under investigation include: Placebo (DRUG), JNJ-53718678 (DRUG).

Who is sponsoring clinical trial NCT02593851?

This trial is sponsored by Janssen Sciences Ireland UC, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02593851's enrollment target sits among peer trials

45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02593851, the US trial registry maintained by the National Library of Medicine. NCT02593851 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.