Clinical Laboratory Testing. Clinical laboratory tests will be performed by the study sites’ local laboratories. Blood and urine samples will be collected, as per the SOE (Section 3) and will be prepared using standard procedures. A repeat measurement of clinical laboratory testing is permitted for eligibility determination. Other clinical laboratory retests may be permitted once in certain scenarios with CCI CCI approval. Such scenarios may include laboratory processing error, results inconsistent with subject’s historical values/medical history, or other extenuating circumstances such as a recent or intercurrent illness potentially affecting screening laboratory results. The clinical laboratory that will perform the tests will provide the reference ranges for all clinical laboratory parameters. Abnormal clinical laboratory values will be flagged as either high or low (or normal or abnormal) based on the reference ranges for each laboratory parameter. The following clinical laboratory assessments will be performed at site or laboratory appointed by site: Hematology Complete blood count (CBC) including white blood cell (WBC) count with differential count, red blood cell (RBC) count, platelet count, hematocrit, hemoglobin, red blood cell indices Coagulation Prothrombin time, partial thromboplastin time, and international normalized ratio (INR) Serum chemistry Alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total and direct), blood urea nitrogen (BUN), creatinine, lipase, serum creatine kinase, bicarbonate or total carbon dioxide, sodium, potassium, chloride, glucose, total protein, albumin, phosphate, calcium, and amylase Urinalysis Urinalysis will be performed with microscopy at indicated. Additional urinalysis may be performed as clinically indicated. It is not required to have the results from the urinalysis performed at screening before beginning study drug dosing, unless medically necessary to establish eligibility (at investigator’s discretion) Direct viral tests SARS-CoV-2 rapid test, rapid influenza diagnostic test Other analyses Female subjects: Pregnancy test (β-HCG; urine at screening and urine or serum after screening) Samples for the following laboratory tests will be sent to the sponsor or a designee for analysis: • Viral Load (as measured by RT-PCR and viral titre) • Treatment-emergent amino acid substitutions in DENV NS5 polymerase • DENV Serotype Testing • NS1 Antigen • Plasma Biomarker • Pharmacokinetic Assessment
Clinical Laboratory Testing. Clinical laboratory tests will be performed by the clinical sites’ local laboratories. Blood and urine samples will be collected and prepared using standard procedures. Repeat clinical laboratory tests may be performed at the discretion of the investigator, if necessary, to evaluate inclusion and exclusion criteria or clinical laboratory abnormalities. The clinical laboratory that will perform the tests will provide the reference ranges for all clinical laboratory parameters. Abnormal clinical laboratory values will be flagged as either high or low (or normal or abnormal) based on the reference ranges for each laboratory parameter. Clinical laboratory testing will occur at screening; check-in; on Day 4; prior to discharge on Day 8 (healthy subjects) or Day 11 (hepatically impaired subjects); and at EOS. Clinical laboratory testing will occur at screening; check-in; Days 4, 8, and 12; and at EOS. The following clinical laboratory assessments will be performed for Parts 1 and 2: Hematology Absolute neutrophil count and differential, hematocrit, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, leukocyte count and differential (basophils, eosinophils, lymphocytes, monocytes, and neutrophils [absolute and differential]), mean corpuscular volume, platelet count, red blood cell count, and red blood cell distribution width Coagulation International normalized ratio, partial thromboplastin time, and prothrombin time Serum chemistry Alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin (total), blood urea nitrogen, calcium, carbon dioxide, chloride, cholesterol (total, high-density lipoprotein, and calculated low-density lipoprotein), creatinine, gamma-glutamyltransferase, globulin, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, triglycerides, and uric acid Urinalysis Bilirubin, color, glucose, ketones, leukocyte esterase, reflex microscopy (performed if dipstick is positive for protein or the blood value is 1+ or greater; and includes bacteria, casts, crystals, epithelial cells, red blood cells, and white blood cells), nitrites, occult blood, pH, protein, specific gravity, turbidity, and urobilinogen Serology Hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody types 1 and 2 (screening only) Other analyses All subjects: Urine drug screen (alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine m...
