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Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Relative Bioavailability | Experimental | Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences. |
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| Part 2: Food Effect | Experimental | Participants will receive three doses of the selected formulation of BGB-43395 under fasted, low-fat, or high-fat conditions in separate periods across various sequences. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-43395 | Drug | Administered orally as solid dispersion tablet or salt tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) | PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2 | |
| Part 1 and 2: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) | PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2 | |
| Part 1 and 2: Maximum Observed Concentration (Cmax) | PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2 | |
| Part 1 and 2: Time of the Maximum Observed Concentration (Tmax) | PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2 | |
| Part 1 and 2: Apparent Terminal Elimination Half-life (t1/2) | PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2 | |
| Part 1 and 2: Apparent Total Clearance (CL/F) | PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2 | |
| Part 1 and 2: Apparent Volume of Distribution (Vz/F) | PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Approx 38 days in Part 1 and 45 days in part 2 | |
| Number of participants with clinically significant laboratory values | Approx 38 days in Part 1 and 45 days in part 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Cru, Daytone Beach | Daytona Beach | Florida | 32117-5116 | United States |
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| BGB-43395 | Drug | Administered orally as solid dispersion tablet or salt tablet |
|
| Number of participants with clinically significant electrocardiogram (ECG) results | Approx 38 days in Part 1 and 45 days in part 2 |
| Number of participants with clinically significant vital sign measurements | Approx 38 days in Part 1 and 45 days in part 2 |