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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Viruses

In brief

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.

Key facts

Study ID

NCT02935673

Run by

Janssen Research & Development, LLC

People needed

49

Starts

2016-10-25

Expected to finish

2018-07-17

Last updated by the study team

2019-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospitalized (or in emergency room prior to hospitalization) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization
• Diagnosed with respiratory syncytial virus (RSV) infection based on polymerase chain reaction (PCR)-based assay with or without co infection with another respiratory pathogen (eg, influenza, human metapneumovirus, or bacteria)
• With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population and/or the RSV infection. This determination must be recorded in the participant's source documents and initialed by the investigator
• A woman must have a negative urine beta human chorionic gonadotropin at screening
• A woman must agree not to donate eggs (ova, oocytes) during the study and for at least 44 days after receiving the last dose of study drug
• Contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies A woman must be of non-childbearing potential defined as either: a) Postmenopausal: a postmenopausal state is defined as more than (>) 45 years and no menses for 12 consecutive months without an alternative medical cause, OR Permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy. b) Of childbearing potential and, if heterosexually active, also included: practicing a highly effective method of contraception (failure rate of less than (<) 1percent (%) per year when used consistently and correctly)
• Participants must have a body weight of at least 50.0 kilogram, at screening

You may not qualify if…

• Participants who are not expected to survive for more than 48 hours
• Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization
• Participants who are considered by the investigator to be immuno-compromised within the past 12 months, whether due to underlying medical condition (example, malignancy or genetic disorder) or medical therapy (example, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant)
• Participants with a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis
• Participants undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR, determined by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) of (<) 60 milliliters per minute (mL/min) per 1.73 meter square (m\^2)
• Participants with 1 or more of the following laboratory abnormalities at screening as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table: Hemoglobin <9.5 gram per deciliter (g/dL), Platelet count <75,000 per millimeter cube (/mm\^³), White blood cell count <1,000/mm\^³, Absolute neutrophil count <1,000/mm\^³

Where it is running

• Study site — Orange, California, United States
• Study site — Stanford, California, United States
• Study site — Eustis, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — St Louis, Missouri, United States
• Study site — Butte, Montana, United States
• Study site — Rochester, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Bahía Blanca, Argentina
• Study site — Barrio Parque Velez Sarfield, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Ciudad de Buenos Aires, Argentina
• Study site — Ciudad de La Plata, Argentina
• Study site — Córdoba, Argentina
• Study site — La Plata, Argentina
• Study site — Rosario, Argentina
• Study site — Cairns, Australia
• Study site — Geelong, Australia
• Study site — Melbourne, Australia
• Study site — South Brisbane, Australia
• Study site — Sydney, Australia
• Study site — Bruges, Belgium
• Study site — Lier, Belgium
• Study site — Fresno, California, United States

Full record on ClinicalTrials.gov

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