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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-BGB-16673

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2526
      • Fortrea Clinical Research Unit Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm: [14C]-BGB-16673; Participants will receive a single dose of [14C]-BGB-16673	Drug: [14C]-BGB-16673; Administered orally as suspension in lipid vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director Study Director, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Actual): March 27, 2025
• Study Completion (Actual): March 27, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BGB-16673-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No