Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUG[14C]-BGB-16673
Administered orally as suspension in lipid vehicle
Sponsors
BeiGene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18.0 and 32.0 kg/m², inclusive. * Good health, as determined by no clinically significant findings from medical history. * History of a minimum of 1 bowel movement per day. * Able to comprehend and are willing to sign the Informed Consent Form (ICF) and abide by the study restrictions.
Exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). * Confirmed systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, or pulse rate \>100 or \<40 beats per minute. * Alcohol consumption of \>21 units per week for males. * Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in. * Ingestion of caffeine-containing foods or beverages within 48 hours of check-in or intend to ingest caffeine-containing foods or beverages until end of study. * Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in. * Ingestion of Seville orange- or grapefruit-containing foods or beverages within 7 days prior to check-in. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of BGB-16673 major metabolites in plasma and excreta | Approximately 35 Days |
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Clinically Significant Laboratory Values | Approximately 9 weeks |
| Number of Participants with Clinically Significant Electrocardiogram (ECG) Results | Approximately 9 weeks |
| Number of Participants with Clinically Significant Vital Sign Measurements | Approximately 9 weeks |
| Number of Participants with Adverse Events (AEs) | Approximately 35 days |
Countries
United States
Outcome results
None listed