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NCT02935673 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus

A Phase 2 study, sponsored by Janssen Research & Development.

Terminated
Registry status
Phase 2
Development phase
49
Enrollment target

NCT02935673: Clinical Trial Phase 2 study, sponsored by Janssen Research & Development.

NCT02935673 is a Phase 2 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02935673, a Phase 2 study, was terminated before completion, sponsored by Janssen Research & Development.

TERMINATED
Registry status
Phase 2
Development phase
49 participants
Enrollment target

Study Summary

The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK model derived from healthy volunteers in hospitalized adults who are infected with respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with respiratory syncytial virus (RSV) infection the dose response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

Primary Outcome

Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.

Interventions

  • DRUG Placebo
  • DRUG lumicitabine

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2016-10-25
Est. Completion 2018-07-17
Phase Phase 2
Janssen Research & Development

593 total trials

Why NCT02935673 stopped before completion

NCT02935673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).

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

NCT02935673 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02935673 about?

NCT02935673 is a clinical study titled "Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus". The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK model derived from healthy volunteers in hospitalized adults who are infected with respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with respiratory syncytial virus (RSV) infect...

What is the current status of trial NCT02935673?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2016-10-25. Estimated completion is 2018-07-17.

What interventions are being tested in trial NCT02935673?

The interventions under investigation include: Placebo (DRUG), lumicitabine (DRUG).

Who is sponsoring clinical trial NCT02935673?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02935673's enrollment target sits among peer trials

49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT02935673, the US trial registry maintained by the National Library of Medicine. NCT02935673 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.