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Last Updated: September 28, 2022

CLINICAL TRIALS PROFILE FOR LUMICITABINE


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Clinical Trials for Lumicitabine

Trial ID Title Status Sponsor Phase Summary
NCT02935673 ↗ 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 Terminated Janssen Research & Development, LLC Phase 2 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.
NCT03189498 ↗ A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function Completed Janssen Pharmaceutica N.V., Belgium Phase 1 The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease [ESRD] with or without hemodialysis) compared to adult participants with normal renal function.
NCT03332459 ↗ A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection Completed Janssen Research & Development, LLC Phase 2 The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned study-related visit in a feeding Phase 2 study (64041575RSV2004).
NCT03333317 ↗ A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respir Terminated Janssen Research & Development, LLC Phase 2 The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) 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).
NCT03441529 ↗ A Crossover Study to Assess the Effect of Intravenous Infusion of Piperacillin/Tazobactam on the Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) in Healthy Adult Participants Completed Janssen Research & Development, LLC Phase 1 The main purpose of this study is to evaluate the effect of intravenous (IV) infusions of piperacillin/tazobactam on the pharmacokinetics (PK) of JNJ-63549109 after a single oral dose of lumicitabine in healthy adult participants.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Lumicitabine

Condition Name

Condition Name for
Intervention Trials
Respiratory Syncytial Viruses 2
Healthy 2
Respiratory Syncytial Virus Infections 1
Metapneumovirus 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Virus Diseases 3
Infection 1
Communicable Diseases 1
Renal Insufficiency 1
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Clinical Trial Locations for Lumicitabine

Trials by Country

Trials by Country for
Location Trials
United States 50
Canada 9
Belgium 5
Spain 4
Taiwan 4
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Trials by US State

Trials by US State for
Location Trials
New York 4
California 4
Ohio 3
Missouri 3
Georgia 3
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Clinical Trial Progress for Lumicitabine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 4
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Terminated 3
Completed 3
Withdrawn 1
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Clinical Trial Sponsors for Lumicitabine

Sponsor Name

Sponsor Name for
Sponsor Trials
Janssen Research & Development, LLC 6
Janssen Pharmaceutica N.V., Belgium 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 7
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