Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PBI-200 · 4 trials · 5 indications
Maximum (peak) plasma drug concentration
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.
Apparent terminal elimination half-life, calculated as ln(2)/kel.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Single-sequence, 3-period | EXPERIMENTAL | Period 1: single dose of PBI-200; Period 2: daily dosing of ritonavir with a single dose of PBI-200 co-administered once ritonavir steady state reached; Period 3: daily dosing of cobicistat with a single dose of PBI-200 co-administered once cobicistat steady state reached. |
| [14C]-PBI-200 Treated | EXPERIMENTAL | \[14C\]-labeled PBI-200 will be administered as a single dose |
| Capsule | EXPERIMENTAL | Study drug will be administered with water after an overnight fast. |
| Tablet | EXPERIMENTAL | Study drug will be administered with water after an overnight fast. |
| Suspension | EXPERIMENTAL | Study drug will be administered with water after an overnight fast. |
| 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 Tablet | DRUG | PBI-200 is a TRK inhibitor |
| Ritonavir Oral Tablet | DRUG | Ritonavir is a potent CYP3A inhibitor |
| Cobicistat Oral Tablet | DRUG | Cobicistat is a potent CYP3A inhibitor |
| [14C]-PBI-200 | DRUG | \[14C\]-radio-labeled-PBI-200 |
| PBI-200 Capsule | DRUG | Single dose of PBI-200 capsule |
| PBI-200 Suspension | DRUG | Single dose of PBI-200 suspension |
| PBI-200 | DRUG | Single dose of PBI-200 |
Inclusion Criteria: * Male or female between 18 and 55 years of age (inclusive). * Body Mass Index (BMI) between 18.0 and 32.0 kg/m² (inclusive). * Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness. Exclusion Criteria: * History or presence of clinically sign...
PBI-200 is an investigational small molecule being studied in healthy volunteers for food effect, absorption, metabolism, excretion, formulation bridging, and drug-drug interaction. It is not approved for any disease and remains in Phase 1 clinical development.
PBI-200 is being developed by Biohaven Ltd., a biopharmaceutical company traded on the New York Stock Exchange under the ticker BHVN.
PBI-200 is in Phase 1 clinical development. It is investigational and not yet approved by regulatory authorities. All four completed trials were early-stage studies in healthy volunteers.
PBI-200 has completed four Phase 1 trials: NCT05160389 (food effect), NCT05238337 (absorption, metabolism, excretion), NCT05690932 (formulation bridging and food effect), and NCT05692570 (drug-drug interaction with ritonavir or cobicistat). All were conducted in the United States.
PBI-200 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials in healthy volunteers, but no efficacy or approval data have been reported.