Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PBI-200 Tablet, [14C]-PBI-200
PBI-200 · 4 trials · 5 indications
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.
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, 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.
| 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. |
| [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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| PBI-200 | DRUG | Single dose of PBI-200 |
| [14C]-PBI-200 | DRUG | \[14C\]-radio-labeled-PBI-200 |
| PBI-200 Tablet | DRUG | Single dose of PBI-200 tablet |
| PBI-200 Capsule | DRUG | Single dose of PBI-200 capsule |
| PBI-200 Suspension | DRUG | Single dose of PBI-200 suspension |
| Ritonavir Oral Tablet | DRUG | Ritonavir is a potent CYP3A inhibitor |
| Cobicistat Oral Tablet | DRUG | Cobicistat is a potent CYP3A inhibitor |
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...
PBI-200 is a small molecule drug candidate developed by Biohaven Ltd. (ticker BHVN). It is in Phase 1 clinical development, with four completed Phase 1 trials conducted in the United States. Its therapeutic indications have not been disclosed. The trials enrolled healthy volunteers and studied drug interactions, formulation bridging, food effects, and absorption, metabolism, and excretion.
PBI-200 is being developed by Biohaven Ltd., which trades under the ticker BHVN. Biohaven is the sponsor of the four completed Phase 1 trials of PBI-200, all of which were conducted in the United States in healthy volunteers.
PBI-200 is in Phase 1 clinical development. All four of its clinical trials are Phase 1 studies, and all four are completed. There are currently no active trials of PBI-200. The studies enrolled a total of 76 participants, all healthy volunteers.
PBI-200 has been studied in four completed Phase 1 trials: NCT05692570, a drug-drug interaction study with ritonavir or cobicistat in 21 healthy volunteers; NCT05690932, a formulation bridging and food effect study in 33 healthy volunteers; NCT05238337, an absorption, metabolism, and excretion study of [14C] PBI-200 in 6 healthy male volunteers; and NCT05160389, a food effect study in 16 healthy volunteers.
Yes. PBI-200 is also referred to as PBI-200 Tablet and [14C]-PBI-200. The [14C] label refers to the radiolabeled form used in the absorption, metabolism, and excretion study NCT05238337. These names all refer to the same Biohaven Ltd. drug candidate.