[14C]-BGB-16673 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the body absorbs, breaks down, and eliminates a new drug called [14C]-BGB-16673, an experimental treatment. Researchers will study its presence in blood, urine, and stool after a single dose. Healthy men with regular daily bowel movements and no major health issues are suitable candidates for the trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy participants and excludes those with significant medical conditions, it's likely that participants should not be on any regular medications.
Is there any evidence suggesting that [14C]-BGB-16673 is likely to be safe for humans?
Research has shown that BGB-16673, a new treatment under study, has a safe and manageable safety profile in early trials with participants. These findings come from studies where no unexpected side effects were reported compared to similar treatments targeting BTK, a protein involved in cell growth. So far, the treatment has been tested in individuals with certain blood cancers, and no unusual or severe toxicities have been observed. This suggests that BGB-16673 could be considered safe based on the data from these initial studies.12345
Why do researchers think this study treatment might be promising?
[14C]-BGB-16673 is unique because it introduces a new active ingredient, [14C]-BGB-16673, which researchers are eager to explore for its potential benefits. Unlike standard treatments that often rely on more established compounds, this drug represents a novel approach to tackling the condition at hand. Researchers are particularly excited about its innovative mechanism of action, which could offer a fresh perspective on treatment efficacy and safety. This excitement stems from the possibility of uncovering new therapeutic pathways that current treatments don't address.
What evidence suggests that [14C]-BGB-16673 could be effective?
Research has shown that BGB-16673, a new drug, offers promising results for treating certain blood cancers. In studies involving patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), 84% experienced a reduction in cancer symptoms, leading to improved well-being for many. Additionally, the benefits of BGB-16673 persisted over time, even for those who had undergone multiple treatments. These findings suggest that BGB-16673 could be an effective treatment option for these conditions.46789
Who Is on the Research Team?
Study Director Study Director
Principal Investigator
BeiGene
Are You a Good Fit for This Trial?
This trial is for healthy men with a BMI between 18.0 and 32.0, who have at least one bowel movement daily, can understand and sign the consent form, and have no significant medical history findings.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of [14C]-BGB-16673
Metabolism and Excretion Monitoring
Participants are monitored for absorption, metabolism, and excretion of the drug, with sample collection from plasma, urine, and feces
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- [14C]-BGB-16673
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeiGene
Lead Sponsor