Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05935917 | Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults | PHASE1 | COMPLETED | 44 | — | — | May 30, 2023 | Sep 27, 2023 | Jan 15, 2025 | 1 | United States |
Assess maximum observed plasma concentration of Brincidofovir
Assess area under the plasma concentration-time curve from time 0 to time of the last measurable concentration (AUC 0 - last) of Brincidofovir
Assess area under the plasma concentration-time curve from time 0 to infinity (AUC 0 - inf) of Brincidofovir
Incidence of treatment-emergent AEs, treatment-related AEs, severe AEs, AEs leading to withdrawal and serious adverse events
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal heart rate
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal respiratory rate
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal Systolic Blood Pressure
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal body temperature
Descriptive statistical summary (summarized by treatment, study day, and time) of Total Protein, Albumin, Globulin
Descriptive statistical summary (summarized by treatment, study day, and time) of albumin/globulin ratio
Descriptive statistical summary (summarized by treatment, study day, and time) of alkaline phosphatase, ALT, AST, GGT and Creatine phosphokinase
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
Descriptive statistical summary (summarized by treatment, study day, and time) of serum chloride, CO2, serum sodium and serum potassium
Descriptive statistical summary (summarized by treatment, study day, and time) of creatinine
Descriptive statistical summary (summarized by treatment, study day, and time) of eGFR
Descriptive statistical summary (summarized by treatment, study day, and time) of LDH
Descriptive statistical summary (summarized by treatment, study day, and time) of basophils, eosinophils lymphocytes, monocytes and neutrophils
Descriptive statistical summary (summarized by treatment, study day, and time) of leukocytes and platelets
Descriptive statistical summary (summarized by treatment, study day, and time) of basophils/leukocytes, eosinophils//leukocytes, lymphocytes//leukocytes, monocytes//leukocytes and neutrophils//leukocytes
Descriptive statistical summary (summarized by treatment, study day, and time) of erythrocytes
Descriptive statistical summary (summarized by treatment, study day, and time) of erythrocytes MCV
Descriptive statistical summary (summarized by treatment, study day, and time) of hematocrit
Descriptive statistical summary (summarized by treatment, study day, and time) of hemoglobin
| Arm | Type | Description |
|---|---|---|
| Treatment AB - Form H (test tablet) first | ACTIVE_COMPARATOR | Treatment AB: Participants assigned to Treatment AB in Period 1, will be given a single 100 mg tablet of Form H (test tablet). In Period 2, participants will be given a single 100 mg tablet of Form II (reference tablet) after a 14 day washout period. |
| Treatment BA - Form II (reference tablet) first | ACTIVE_COMPARATOR | Treatment BA: Participants assigned to Treatment BA in Period 1, will be given a single 100 mg tablet of Form II (reference tablet). In Period 2, participants will be given a single 100 mg tablet of Form H (test tablet) after a 14 day washout period. |
| Name | Type | Description |
|---|---|---|
| Brincidofovir | DRUG | 100 mg tablet of Form H and 100 mg tablet of Form II |
Inclusion Criteria: * Able and willing to provide informed consent voluntarily signed by participant. * Male or female between 18 to 70 years of age, inclusive at screening. * Body mass index (BMI) from 18 to 32 kg/m² with a minimum body weight of ≥ 50 kg, inclusive at screening. * Women must be of...