A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment

NCT07856004 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BGB-16673-108
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to understand how the body processes tacabrutideg in adults with different levels of liver function (normal, moderate impairment, and severe impairment).

Conditions

Hepatic Impairment; Healthy Adult Participants

Keywords

tacabrutideg; pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-tlast) of Tacabrutideg

  Days 1-20

• AUC from time 0 extrapolated to infinity (AUC0-∞) of Tacabrutideg

  Days 1-20

• Maximum observed plasma concentration (Cmax) of Tacabrutideg

  Days 1-20

• Time to reach maximum observed plasma concentration (Tmax) of Tacabrutideg

  Days 1-20

• Apparent terminal elimination half-life (t½) of Tacabrutideg

  Days 1-20

• Apparent oral clearance (CL/F) of Tacabrutideg

  Days 1-20

• Apparent volume of distribution (Vz/F) of Tacabrutideg

  Days 1-20

• Fraction unbound (Fu) of Tacabrutideg

  Day 1

Secondary Outcomes (4)

• Number of Participants with Adverse Events (AEs)

  Approximately 30 days

• Number of Participants with Laboratory Abnormalities

  Approximately 20 days

• Number of Participants with Clinically Significant Vital Signs Measurements

  Approximately 20 days

• Number of Participants with Clinically Significant Electrocardiogram (ECG) Values

  Approximately 20 days

Study Arms (3)

Group 1: Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment will receive a single dose of tacabrutideg on Day 1.

Drug: Tacabrutideg

Group 2: Normal Hepatic Function

EXPERIMENTAL

Participants with normal hepatic function will receive a single dose of tacabrutideg on Day 1.

Drug: Tacabrutideg

Group 3: Severe Hepatic Impairment

EXPERIMENTAL

Participants with severe hepatic impairment will receive a single dose of tacabrutideg on Day 1.

Drug: Tacabrutideg

Interventions

Tacabrutideg DRUG

Single dose of tacabrutideg administered orally.

Also known as: BGB-16673

Group 1: Moderate Hepatic Impairment; Group 2: Normal Hepatic Function; Group 3: Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) between ≥ 18.0 and 40 kg/m\^2, inclusive
• Generally stable health (except for hepatic impairment in hepatically impaired participants) as determined by the Investigator based on medical evaluation at Screening and Check-in, with no clinically significant findings that would interfere with study participation
• Female participants of non-childbearing potential who meet any of the following criteria: surgically sterile or postmenopausal
• Male participants must agree to use a condom during sexual intercourse and refrain from sperm donation for the duration of the study and for 30 days after the last dose of tacabrutideg. For nonsterile male participants with a female partner of childbearing potential, use of an additional highly effective method of contraception by the female partner is highly recommended during this period.
• Meets National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria for moderate or severe hepatic impairment at screening:
• Moderate hepatic impairment: Total bilirubin \> 1.5 to 3 × upper limit of normal (ULN), any aspartate aminotransferase (AST)
• Severe hepatic impairment: Total bilirubin \> 3 × ULN, any AST
• Clinically stable hepatic disease, in the opinion of the investigator, with no clinically significant worsening of hepatic function within 4 weeks prior to dosing
• Normal hepatic function, including total bilirubin ≤ ULN and AST ≤ ULN
• Clinical laboratory test results and physical examination findings within normal limits or judged as not clinically significant by the investigator

You may not qualify if:

• Prior exposure to any BTK protein degraders
• Underlying medical conditions (including laboratory abnormalities) other than stable hepatic impairment
• History of severe bleeding disorder or history of unexplained spontaneous bleeding requiring blood transfusion or other medical or surgical intervention
• Positive urine drug screen or alcohol urine/breath test/blood results at Screening or Check-in
• Acute hepatic disease or rapidly deteriorating hepatic function
• History of liver transplantation
• Previously diagnosed hepatocellular carcinoma, or history of cholestatic liver disease or biliary sepsis within the past 2 years
• Any known or suspected hepatic disease
• Clinically significant abnormalities in liver function tests at Screening
• Require ongoing use of prescription or nonprescription medications, including herbal supplements (unless the medication is not expected to interfere with the pharmacokinetics, safety, or tolerability of the study drug)

Sponsors & Collaborators

• BeOne Medicines: lead

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 22, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

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