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Lumicitabine

Generic Name
Lumicitabine
Drug Type
Small Molecule
Chemical Formula
C18H25ClFN3O6
CAS Number
1445385-02-3
Unique Ingredient Identifier
BNW5PQ52G1
Background

Lumicitabine is under investigation in clinical trial NCT03010059 (A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations).

Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus

Phase 2
Withdrawn
Conditions
Metapneumovirus
Interventions
Drug: Placebo
First Posted Date
2018-04-19
Last Posted Date
2018-11-15
Lead Sponsor
Janssen Research & Development, LLC
Registration Number
NCT03502694
Locations
🇫🇷

Hôpital Tenon, Paris, France

🇺🇸

MemorialCare Research Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States

🇺🇸

Lake Internal Medicine Associates, Eustis, Florida, United States

and more 109 locations

A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants

Phase 1
Terminated
Conditions
Healthy
Interventions
First Posted Date
2018-03-19
Last Posted Date
2018-07-23
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
18
Registration Number
NCT03468777
Locations
🇧🇪

Clinical Pharmacology Unit, Merksem, Belgium

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

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Piperacillin/Tazobactam
First Posted Date
2018-02-22
Last Posted Date
2018-06-07
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
18
Registration Number
NCT03441529
Locations
🇧🇪

Clinical Pharmacology Unit, Merksem, Belgium

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

Phase 2
Completed
Conditions
Respiratory Syncytial Virus Infections
Interventions
Drug: Placebo
First Posted Date
2017-11-06
Last Posted Date
2021-04-13
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
7
Registration Number
NCT03332459
Locations
🇯🇵

National Hospital Organization Niigata National Hospital, Niigata, Japan

🇯🇵

Fukuyama City Hospital, Fukuyama, Japan

🇯🇵

National Hospital Organization Beppu Medical Center, Oita, Japan

and more 1 locations

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 Respiratory Syncytial Virus

Phase 2
Terminated
Conditions
Respiratory Syncytial Viruses
Interventions
Drug: Placebo
First Posted Date
2017-11-06
Last Posted Date
2019-12-23
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
7
Registration Number
NCT03333317
Locations
🇯🇵

Takatsuki General Hospital, Osaka, Japan

🇯🇵

Shikoku Medical Center for Children and Adults, Zentsuji, Japan

🇵🇱

Plejady Medical Center, Malopolska, Poland

and more 26 locations

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

Phase 2
Terminated
Conditions
Respiratory Syncytial Viruses
Interventions
Drug: Placebo
First Posted Date
2016-10-17
Last Posted Date
2019-12-24
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
49
Registration Number
NCT02935673

Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2016-07-14
Last Posted Date
2025-02-03
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
103
Registration Number
NCT02833831

A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus

Phase 2
Completed
Conditions
Respiratory Syncytial Virus Infections
Interventions
Drug: Placebo
First Posted Date
2016-02-04
Last Posted Date
2025-02-04
Lead Sponsor
Alios Biopharma Inc.
Target Recruit Count
9
Registration Number
NCT02673476
Locations
🇸🇬

Raffles Hospital, Singapore, Singapore

🇺🇸

St Lucie Medical Center, Port Saint Lucie, Florida, United States

🇺🇸

The Research Center, Inc., Hialeah, Florida, United States

and more 18 locations

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Participants

Phase 1
Completed
Conditions
Respiratory Syncytial Virus Infections
Interventions
First Posted Date
2015-06-23
Last Posted Date
2016-07-11
Lead Sponsor
Janssen Pharmaceutical K.K.
Target Recruit Count
24
Registration Number
NCT02478333

A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176

Phase 1
Completed
Conditions
Respiratory Syncytial Virus Infections
Interventions
First Posted Date
2014-09-04
Last Posted Date
2017-10-31
Lead Sponsor
Alios Biopharma Inc.
Target Recruit Count
12
Registration Number
NCT02231671
Locations
🇬🇧

Quotient Clinical, Nottingham, United Kingdom

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