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
Condition: Respiratory Syncytial Viruses
MeSH terms: Virus Diseases
Intervention: lumicitabine; Placebo
Intervention description: Oral administration of lumicitabine as tablet.; Oral administration of matching placebo.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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