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The purpose of this study is to investigate the effect of coadministration of phenytoin or itraconazole on the pharmacokinetics of BGB-16673 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: BGB-16673 + Phenytoin (CYP3A Inducer) | Experimental | Participants will receive multiple doses of Phenytoin to determine its effect on BGB-16673 |
|
| Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor) | Experimental | Participants will receive multiple doses of Itraconazole to determine its effect on BGB-16673 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-16673 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673 | Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 | |
| Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673 | Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 | |
| Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-16673 | Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-16673 | Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 | |
| Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-16673 | Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc | Madison | Wisconsin | 53704-2526 | United States |
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D010672 | Phenytoin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Administered orally |
|
| Phenytoin | Drug | Administered orally |
|
| Part A and Part B: Apparent Total Clearance (CL/F) of BGB-16673 | Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 |
| Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-16673 | Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 |
| Part A and Part B: Number of Participants with Adverse Events (AEs) | Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 | Up to approximately 36 days |
| Part A and Part B: Number of Participants with Clinically Significant Laboratory Values | Up to approximately 36 days |
| Part A and Part B: Number of Participants with Clinically Significant Electrocardiogram (ECG) results | Up to approximately 36 days |
| Part A and Part B: Number of Participants with Clinically Significant Vital Sign Measurements | Up to approximately 36 days |
| D010879 |
| Piperazines |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |