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Phase 1 study in healthy subjects to determine the effect of an 8-hour fast from food on the pharmacokinetics of [14C]-BGB-3111.
This study will be an open-label, non-randomized study to evaluate the pharmacokinetics of [14C]-BGB-3111 when administered in healthy male subjects following at least an 8-hour fast from food (not including water).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Subjects will be administered a single oral dose of 320 mg of [14C]-BGB-3111 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-BGB-3111 | Drug | 20-mg capsule containing ~200 μCi of [14C]-BGB-3111, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC) | Up to 13 days | |
| Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111 | Up to 13 days | |
| Pharmacokinetic Parameter: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111 | Up to 13 days | |
| Pharmacokinetic Parameter: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111 | Up to 13 days | |
| Pharmacokinetic Parameter: Half-life Period of (T1/2) of [14C]-BGB-3111 | Up to 13 days | |
| Pharmacokinetic Parameter: apparent systemic clearance (CL/F) of [14C]-BGB-3111 | Up to 13 days | |
| Pharmacokinetic Parameter: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111 | Up to 13 days | |
| Blood and plasma concentrations of total radioactivity: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111 | Up to 13 days | |
| Blood and plasma concentrations of total radioactivity: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111 | Up to 13 days | |
| Blood and plasma concentrations of total radioactivity of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC) |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize and identify metabolites of [14C]-BGB-3111 | plasma, urine, and feces collection | Up to 13 days |
| plasma and urine concentrations of BGB-3111 | plasma and urine collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Novotony, MD | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc., | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
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| BGB-3111 |
| Drug |
Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111 |
|
| Up to 13 days |
| Blood and plasma concentrations of total radioactivity: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111 | Up to 13 days |
| Blood and plasma concentrations of total radioactivity: Half-life Period of (T1/2) of [14C]-BGB-3111 | Up to 13 days |
| Blood and plasma concentrations of total radioactivity: apparent systemic clearance (CL/F) of [14C]-BGB-3111 | Up to 13 days |
| Blood and plasma concentrations of total radioactivity: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111 | Up to 13 days |
| Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the amount excreted in urine per sampling interval (Aeu) | Up to 13 days |
| Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the cumulative amount excreted in urine per sampling interval (Cum Aeu) | Up to 13 days |
| Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the percentage of drug or radioactive dose excreted in urine per sampling interval (%Feu) | Up to 13 days |
| Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the cumulative percentage of drug or radioactive dose excreted in urine (Cum %Feu) | Up to 13 days |
| Urinary recovery of total radioactivity as assessed by the renal clearance (CLR; for BGB-3111 only) | Up to 13 days |
| Fecal recovery of total radioactivity as assessed by the amount of [14C]-BGB-3111 excreted in feces per sampling interval (Aef) | Up to 13 days |
| Fecal recovery of total radioactivity as assessed by the cumulative amount of [14C]-BGB-3111 excreted in feces per sampling interval (Cum Aef) | Up to 13 days |
| Fecal recovery of total radioactivity as assessed by the percentage of radioactive dose excreted in feces per sampling interval (%Fef) | Up to 13 days |
| Fecal recovery of total radioactivity as assessed by the cumulative percentage of radioactive dose excreted in feces per sampling interval (Cum %Fef) | Up to 13 days |
| Mass balance | Urine and fecal collection for Mass Balance Evaluation | Up to 13 days |
| Routes of elimination of [14C]-BGB-3111 | Urine and fecal collection for Metabolite Profiling/Characterization | Up to 13 days |
| up to 13 days |
| Number of Participants experiencing Adverse events (AEs) | up to 13 days |
| Number of Participants experiencing abnormal clinical laboratory evaluations | up to 13 days |