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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05160389 | A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200 | PHASE1 | COMPLETED | 16 | — | — | Nov 17, 2021 | Jan 6, 2022 | Jan 27, 2022 | 1 | United States |
Tmax will be determined from the observed plasma concentration data.
AUC, calculated using linear up/ log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration.
AUC from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/ kel, where kel is the terminal rate constant and Ct is the last measurable concentration.
| Arm | Type | Description |
|---|---|---|
| Fasted | EXPERIMENTAL | Study drug will be administered with water, after an overnight fast. |
| Low-fat Meal | EXPERIMENTAL | Study drug will be administered with water, after an overnight fast, after which time a standard low-fat breakfast will be given. |
| High-fat Meal | EXPERIMENTAL | Study drug will be administered with water, after an overnight fast, after which time a standard high-fat breakfast will be given. |
| Name | Type | Description |
|---|---|---|
| PBI-200 | DRUG | Single dose of PBI-200 |
Key Inclusion Criteria: * Male or non-pregnant, non-lactating female between 18 and 55 years of age (inclusive). * Body Mass Index (BMI) between 18 and 32 kg/m² (inclusive). * Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness. Key Exclusion Criteria: * Histor...