The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy adults. Participants will be randomized to each receive one tablet of Form H and one tablet of Form II,14 days apart and undergo pharmacokinetic testing pre-dose and post-dose to evaluate safety. This is an open-label, single-dose, randomized, two-period, crossover study.
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PK endpoint - Peak Plasma Concentration (Cmax)
Timeframe: Through 96 hours post-dose
PK endpoint - AUClast
Timeframe: Through 96 hours post-dose
PK endpoint - AUCinf
Timeframe: Through 96 hours post-dose
Incidence of treatment adverse events (AEs)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Heart Rate
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Respiratory Rate
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Body Temperature (Celsius)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: Total Protein, Albumin, Globulin (g/dL)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: Albumin/Globulin ratio
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: alkaline phosphatase, ALT, AST, GGT and Creatine phosphokinase (U/L)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: bilirubin (total and direct), BUN, serum calcium, glucose (random), serum phosphate, serum uric acid and serum magnesium (mg/dL)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: serum chloride, CO2, serum sodium and serum potassium (mmol/L)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: Creatinine (g/24h)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: eGFR (ml/min)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: LDH (units/L)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Hematology parameters: basophils, eosinophils, lymphocytes, monocytes and neutrophils (cells/uL)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Hematology parameters: leukocytes and platelets (thousand/uL)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Hematology parameters: proportion of basophils, eosinophils, lymphocytes, monocytes and neutrophils
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: erythrocytes (million/uL)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: erythrocytes mean corpuscular volume (MCV) (fL)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: hematocrit (%)
Timeframe: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: hemoglobin (g/dL)
Timeframe: Through end of study visit (within 14 days after 2nd dose)