A Study of How [14C]-BGB-16673 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]-BGB-16673

• Registration Number: NCT06776679
• Lead Sponsor: BeiGene

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-15
• Study Start: 2025-01-24
• Primary Completion: 2025-03-27
• Study Completion: 2025-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm: [14C]-BGB-16673	[14C]-BGB-16673	Participants will receive a single dose of \[14C\]-BGB-16673

Primary Outcome Measures

Name	Time	Method
Total Radioactivity Recovery (fet1-t2) in Urine and Feces	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
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	Approximately 35 days
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

Trial Locations

Locations (1)

Fortrea Clinical Research Unit Inc; 🇺🇸 Madison, Wisconsin, United States