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

NCT06776679 | Completed Phase 1 FDA Drug

• 1 other identifier: BGB-16673-106
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (4)

• 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

Study Arms (1)

Single Arm: [14C]-BGB-16673

EXPERIMENTAL

Participants will receive a single dose of \[14C\]-BGB-16673

Drug: [14C]-BGB-16673

Interventions

[14C]-BGB-16673 DRUG

Administered orally as suspension in lipid vehicle

Single Arm: [14C]-BGB-16673

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc

Madison, Wisconsin, 53704-2526, United States

Location

Study Officials

• Study Director Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: January 24, 2025
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)