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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-24

Study Completion Date

2025-03-27

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm: [14C]-BGB-16673

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

Group Type EXPERIMENTAL

[14C]-BGB-16673

Intervention Type DRUG

Administered orally as suspension in lipid vehicle

Interventions

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[14C]-BGB-16673

Administered orally as suspension in lipid vehicle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes