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

BeiGene

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: [14C]-BGB-16673

Study type

Interventional

Funder types

Industry

Identifiers

NCT06776679

BGB-16673-106

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.