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This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.
This is a single-dose, two-part crossover formulation bridging (Part A) and tablet food effect (Part B) study in normal, healthy volunteers. Part A will be conducted to evaluate the pharmacokinetics (PK) and relative bioavailability of 3 formulations of PBI-200; each volunteer will serve as their own control. In Part B, PBI-200 tablets will be dosed under fasting and fed (low-fat and high-fat meals) conditions to evaluate the effect of food on the PK of PBI-200.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsule | Experimental | Study drug will be administered with water after an overnight fast. |
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| Tablet | Experimental | Study drug will be administered with water after an overnight fast. |
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| Suspension | Experimental | Study drug will be administered with water after an overnight fast. |
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| Fasted | Experimental | Study drug will be administered with water after an overnight fast. |
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| 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. |
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| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBI-200 Tablet | Drug | Single dose of PBI-200 tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [C(max)] of PBI-200 | Maximum (peak) plasma drug concentration | 8 days |
| Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of th last measurable concentration [AUC(0-t)] | 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. | 8 days |
| AUC of PBI-200 from time zero to infinity [AUC(0-inf)] | 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. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Concentration [T(max)] of PBI-200 | T(max) will be determined from the observed plasma concentration data | 8 days |
| Terminal elimination half-life [T(1/2)] | Apparent terminal elimination half-life, calculated as ln(2)/kel |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Pyramid Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Kinetic Clinical Applications | Springfield | Missouri | 65802 | United States |
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Single-dose, open-label, randomized, three-way crossover design
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| PBI-200 Capsule | Drug | Single dose of PBI-200 capsule |
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| PBI-200 Suspension | Drug | Single dose of PBI-200 suspension |
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| 8 days |
| Incidence, frequency and severity of adverse events (AEs) | 14 days |