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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc

Madison, Wisconsin, 53704-2526, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C]-BGB-16673

Drug

Administered orally as suspension in lipid vehicle

Primary outcomes

  1. Total Radioactivity Recovery (fet1-t2) in Urine and Feces

    Time frame: Approximately 35 Days

  2. Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673

    Time frame: Approximately 35 Days

  3. Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) for Total Radioactivity in Plasma and Whole Blood

    Time frame: Approximately 35 Days

  4. Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673

    Time frame: Approximately 35 Days

  5. 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

    Time frame: Approximately 35 Days

  6. Maximum Observed Plasma Concentration (Cmax) of BGB-16673

    Time frame: Approximately 35 Days

  7. Maximum Observed Plasma Concentration (Cmax) for Total Radioactivity in Plasma and Whole Blood

    Time frame: Approximately 35 Days

  8. Time of the Maximum Observed Plasma Concentration (Tmax) of BGB-16673

    Time frame: Approximately 35 Days

  9. Time of the Maximum Observed Plasma Concentration (Tmax) for Total Radioactivity in Plasma and Whole Blood

    Time frame: Approximately 35 Days

  10. Apparent Terminal Elimination Half-life (t1/2) of BGB-16673

    Time frame: Approximately 35 Days

  11. Apparent Terminal Elimination Half-life (t1/2) for Total Radioactivity in Plasma and Whole Blood

    Time frame: Approximately 35 Days

  12. Urinary recovery of BGB-16673 (fet1-t2)

    Time frame: Approximately 35 Days

  13. Quantitative metabolic profiles of BGB-16673 in plasma and excreta

    Time frame: Approximately 35 Days

  14. Identification of BGB-16673 major metabolites in plasma and excreta

    Time frame: Approximately 35 Days

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Approximately 35 days

  2. Number of Participants with Clinically Significant Laboratory Values

    Time frame: Approximately 9 weeks

  3. Number of Participants with Clinically Significant Electrocardiogram (ECG) Results

    Time frame: Approximately 9 weeks

  4. Number of Participants with Clinically Significant Vital Sign Measurements

    Time frame: Approximately 9 weeks

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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