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.
Primary Objectives: * To evaluate the bioequivalence (BE) of brincidofovir (BCV) hydrate (Form H) tablet and the Form II tablet when administered under fasting conditions in healthy adult participants. * To characterize plasma BCV pharmacokinetics (PK) following single doses of BCV when administered in healthy adult participants. Safety Objective: \- To evaluate the safety of BCV following administration of single dose of 100 mg BCV Form H and BCV Form II tablet in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
100 mg tablet of Form H and 100 mg tablet of Form II
Altasciences
Overland Park, Kansas, United States
PK endpoint - Peak Plasma Concentration (Cmax)
Assess maximum observed plasma concentration of Brincidofovir
Time frame: Through 96 hours post-dose
PK endpoint - AUClast
Assess area under the plasma concentration-time curve from time 0 to time of the last measurable concentration (AUC 0 - last) of Brincidofovir
Time frame: Through 96 hours post-dose
PK endpoint - AUCinf
Assess area under the plasma concentration-time curve from time 0 to infinity (AUC 0 - inf) of Brincidofovir
Time frame: Through 96 hours post-dose
Incidence of treatment adverse events (AEs)
Incidence of treatment-emergent AEs, treatment-related AEs, severe AEs, AEs leading to withdrawal and serious adverse events
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Heart Rate
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal heart rate
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Respiratory Rate
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal respiratory rate
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal Systolic Blood Pressure
Time frame: Through end of study visit (within 14 days after 2nd dose)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Descriptive statistical summary abnormal Body Temperature (Celsius)
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal body temperature
Time frame: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: Total Protein, Albumin, Globulin (g/dL)
Descriptive statistical summary (summarized by treatment, study day, and time) of Total Protein, Albumin, Globulin
Time frame: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: Albumin/Globulin ratio
Descriptive statistical summary (summarized by treatment, study day, and time) of albumin/globulin ratio
Time frame: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: alkaline phosphatase, ALT, AST, GGT and Creatine phosphokinase (U/L)
Descriptive statistical summary (summarized by treatment, study day, and time) of alkaline phosphatase, ALT, AST, GGT and Creatine phosphokinase
Time frame: 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)
Descriptive statistical summary (summarized by treatment, study day, and time) of bilirubin (total and direct), BUN, serum calcium, glucose (random), serum phosphate, serum uric acid and serum magnesium
Time frame: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: serum chloride, CO2, serum sodium and serum potassium (mmol/L)
Descriptive statistical summary (summarized by treatment, study day, and time) of serum chloride, CO2, serum sodium and serum potassium
Time frame: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: Creatinine (g/24h)
Descriptive statistical summary (summarized by treatment, study day, and time) of creatinine
Time frame: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: eGFR (ml/min)
Descriptive statistical summary (summarized by treatment, study day, and time) of eGFR
Time frame: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: LDH (units/L)
Descriptive statistical summary (summarized by treatment, study day, and time) of LDH
Time frame: Through end of study visit (within 14 days after 2nd dose)
Hematology parameters: basophils, eosinophils, lymphocytes, monocytes and neutrophils (cells/uL)
Descriptive statistical summary (summarized by treatment, study day, and time) of basophils, eosinophils lymphocytes, monocytes and neutrophils
Time frame: Through end of study visit (within 14 days after 2nd dose)
Hematology parameters: leukocytes and platelets (thousand/uL)
Descriptive statistical summary (summarized by treatment, study day, and time) of leukocytes and platelets
Time frame: Through end of study visit (within 14 days after 2nd dose)
Hematology parameters: proportion of basophils, eosinophils, lymphocytes, monocytes and neutrophils
Descriptive statistical summary (summarized by treatment, study day, and time) of basophils/leukocytes, eosinophils//leukocytes, lymphocytes//leukocytes, monocytes//leukocytes and neutrophils//leukocytes
Time frame: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: erythrocytes (million/uL)
Descriptive statistical summary (summarized by treatment, study day, and time) of erythrocytes
Time frame: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: erythrocytes mean corpuscular volume (MCV) (fL)
Descriptive statistical summary (summarized by treatment, study day, and time) of erythrocytes MCV
Time frame: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: hematocrit (%)
Descriptive statistical summary (summarized by treatment, study day, and time) of hematocrit
Time frame: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: hemoglobin (g/dL)
Descriptive statistical summary (summarized by treatment, study day, and time) of hemoglobin
Time frame: Through end of study visit (within 14 days after 2nd dose)