Clinical trial NCT06776679: A Study of How [14C]-BGB-16673 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Participants
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-BGB-16673 Following a Single Oral Dose in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2025-01-15
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/Exclusion criteria may apply.

Primary outcomes:
measure: Total Radioactivity Recovery (fet1-t2) in Urine and Feces
timeFrame: Approximately 35 Days
measure: Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673
timeFrame: Approximately 35 Days
measure: Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) for Total Radioactivity in Plasma and Whole Blood
timeFrame: Approximately 35 Days
measure: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673
timeFrame: Approximately 35 Days
measure: 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
timeFrame: Approximately 35 Days
measure: Maximum Observed Plasma Concentration (Cmax) of BGB-16673
timeFrame: Approximately 35 Days
measure: Maximum Observed Plasma Concentration (Cmax) for Total Radioactivity in Plasma and Whole Blood
timeFrame: Approximately 35 Days
measure: Time of the Maximum Observed Plasma Concentration (Tmax) of BGB-16673
timeFrame: Approximately 35 Days
measure: Time of the Maximum Observed Plasma Concentration (Tmax) for Total Radioactivity in Plasma and Whole Blood
timeFrame: Approximately 35 Days
measure: Apparent Terminal Elimination Half-life (t1/2) of BGB-16673
timeFrame: Approximately 35 Days
measure: Apparent Terminal Elimination Half-life (t1/2) for Total Radioactivity in Plasma and Whole Blood
timeFrame: Approximately 35 Days
measure: Urinary recovery of BGB-16673 (fet1-t2)
timeFrame: Approximately 35 Days
measure: Quantitative metabolic profiles of BGB-16673 in plasma and excreta
timeFrame: Approximately 35 Days
measure: Identification of BGB-16673 major metabolites in plasma and excreta
timeFrame: Approximately 35 Days
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Approximately 35 days
measure: Number of Participants with Clinically Significant Laboratory Values
timeFrame: Approximately 9 weeks
measure: Number of Participants with Clinically Significant Electrocardiogram (ECG) Results
timeFrame: Approximately 9 weeks
measure: Number of Participants with Clinically Significant Vital Sign Measurements
timeFrame: Approximately 9 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortrea Clinical Research Unit Inc
state: Wisconsin
Study officials:
affiliation: BeiGene
name: Study Director Study Director
role: STUDY_DIRECTOR
References: