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The purpose of this study is to determine the absorption, metabolism, and excretion of [14C]-BGB-16673 and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces in healthy male participants following a single oral administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm: [14C]-BGB-16673 | Experimental | Participants will receive a single dose of [14C]-BGB-16673 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-BGB-16673 | Drug | Administered orally as suspension in lipid vehicle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Radioactivity Recovery (fet1-t2) in Urine and Feces | Approximately 35 Days | |
| Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673 | Approximately 35 Days | |
| Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) for Total Radioactivity in Plasma and Whole Blood | Approximately 35 Days | |
| Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673 | Approximately 35 Days | |
| Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) for Total Radioactivity in Plasma and Whole Blood | Approximately 35 Days | |
| Maximum Observed Plasma Concentration (Cmax) of BGB-16673 | Approximately 35 Days | |
| Maximum Observed Plasma Concentration (Cmax) for Total Radioactivity in Plasma and Whole Blood | Approximately 35 Days | |
| Time of the Maximum Observed Plasma Concentration (Tmax) of BGB-16673 | Approximately 35 Days | |
| Time of the Maximum Observed Plasma Concentration (Tmax) for Total Radioactivity in Plasma and Whole Blood | Approximately 35 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Approximately 35 days | |
| Number of Participants with Clinically Significant Laboratory Values | Approximately 9 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director 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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| Apparent Terminal Elimination Half-life (t1/2) of BGB-16673 | Approximately 35 Days |
| Apparent Terminal Elimination Half-life (t1/2) for Total Radioactivity in Plasma and Whole Blood | Approximately 35 Days |
| Urinary recovery of BGB-16673 (fet1-t2) | Approximately 35 Days |
| Quantitative metabolic profiles of BGB-16673 in plasma and excreta | Approximately 35 Days |
| Identification of BGB-16673 major metabolites in plasma and excreta | Approximately 35 Days |
| Number of Participants with Clinically Significant Electrocardiogram (ECG) Results |
| Approximately 9 weeks |
| Number of Participants with Clinically Significant Vital Sign Measurements | Approximately 9 weeks |