Lumicitabine

Overview

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).

Title	Posted	Study ID	Phase	Status	Sponsor
Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus	2018/04/19	NCT03502694	Phase 2	Withdrawn	Janssen Research & Development, LLC
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	2018/03/19	NCT03468777	Phase 1	Terminated	Janssen Research & Development, LLC
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	2018/02/22	NCT03441529	Phase 1	Completed	Janssen Research & Development, LLC
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	2017/11/06	NCT03333317	Phase 2	Terminated	Janssen Research & Development, LLC
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	2017/11/06	NCT03332459	Phase 2	Completed	Janssen Research & Development, LLC
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	2016/10/17	NCT02935673	Phase 2	Terminated	Janssen Research & Development, LLC
Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Participants	2016/07/14	NCT02833831	Phase 1	Completed	Janssen Research & Development, LLC
A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus	2016/02/04	NCT02673476	Phase 2	Completed	Alios Biopharma Inc.
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Participants	2015/06/23	NCT02478333	Phase 1	Completed	Janssen Pharmaceutical K.K.
A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176	2014/09/04	NCT02231671	Phase 1	Completed	Alios Biopharma Inc.

Title

Posted

Study ID

Phase

Status

Sponsor

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

2018/04/19

NCT03502694

Phase 2

Withdrawn

Janssen Research & Development, LLC