drugset / Trial / 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

NCT02935673

Phase 2 Terminated 49 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2016-10-25
Primary completion
2018-07-17
Completion
2018-07-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumicitabine Small molecule 250 mg Oral
Subject Lumicitabine Small molecule 500 mg Oral