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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT06776679

Run by

BeiGene

People needed

8

Starts

2025-01-24

Expected to finish

2025-03-27

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

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.
• NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Fortrea Clinical Research Unit Inc — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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