BGB-43395 for Drug Interaction Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the new drug BGB-43395 affects how other common medications work in the body. Participants will take BGB-43395 with drugs like midazolam (used for sedation), celecoxib (a pain reliever), dabigatran (a blood thinner), and rosuvastatin (a cholesterol-lowering drug) to check for interactions. Those who are generally healthy and have no significant medical conditions might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Is there any evidence suggesting that BGB-43395 is likely to be safe for humans?
Why are researchers excited about this trial's treatments?
Researchers are excited about BGB-43395 because it explores how this new compound interacts with common medications like midazolam, celecoxib, dabigatran, and rosuvastatin. Unlike other treatments that are already established, BGB-43395 might offer a unique mechanism of action or improved safety profile when used in combination with these drugs. This study could reveal new insights into potential drug interactions, leading to safer and more effective medication regimens for patients who require these treatments.
What evidence suggests that BGB-43395 could be effective in drug interaction studies?
Research has shown that BGB-43395 targets proteins involved in cell growth, which can slow or stop cancer cell growth. Studies have found that drugs like BGB-43395 effectively treat some cancers, especially breast cancer, by blocking proteins that allow cancer cells to multiply. In this trial, participants will receive BGB-43395 alongside other medications to study its interactions. Part 1 of the trial involves midazolam and celecoxib, while Part 2 involves dabigatran and rosuvastatin. Early results suggest BGB-43395 might work well with other cancer treatments, but more research is needed to confirm its safety and effectiveness.678910
Who Is on the Research Team?
Study Director
Principal Investigator
BeOne Medicines
Are You a Good Fit for This Trial?
This trial is for healthy adults with a body mass index between 18 and 32, who are not pregnant or breastfeeding, and agree to use contraception. Participants must have no significant health issues based on medical exams.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive midazolam and celecoxib alone and with BGB-43395
Treatment Part 2
Participants receive dabigatran and rosuvastatin alone and with BGB-43395
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BGB-43395
Trial Overview
The study tests if the new drug BGB-43395 affects how other common drugs (midazolam, celecoxib, dabigatran etexilate, rosuvastatin) work in the body. Healthy volunteers will receive these medicines to check for interactions.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive dabigatran and rosuvastatin alone and with BGB-43395.
Participants will receive midazolam and celecoxib alone and with BGB-43395.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeOne Medicines
Lead Sponsor
Fortrea
Industry Sponsor
Citations
BGB-43395 Alone or as Part of Combination Therapies in ...
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works ...
2.
jons-online.com
jons-online.com/articles/a-network-meta-analysis-of-treatment-related-adverse-events-of-various-cdk4-6-inhibitors-in-metastatic-breast-cancerA Network Meta-Analysis of Treatment-Related Adverse ...
Ribociclib and abemaciclib were associated with lower grade 3/4 hematologic toxicity compared with palbociclib but were associated with higher gastrointestinal ...
3.
cancernetwork.com
cancernetwork.com/view/combined-study-analysis-determines-best-drug-choices-for-patients-with-advanced-breast-cancerCombined Study Analysis Determines Best Drug Choices ...
Further, patients without ESR1 mutations detected had 1-year OS of 79% (95% CI, 71%-85%) on exemestane and 81% (95% CI, 74%-87%) on fulvestrant ...
4.
ctv.veeva.com
ctv.veeva.com/study/a-study-evaluating-the-efficacy-and-safety-of-multiple-treatment-combinations-in-patients-with-metasA Study Evaluating the Efficacy and Safety of Multiple ...
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or ...
5.
nurenyx.ai
nurenyx.ai/study-search/study/NCT07492641-bgb-43395-plus-letrozole-versus-cdk46i-plus-letrozole-forBGB-43395 Plus Letrozole Versus CDK4/6i ...
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's ...
BGB-43395 - Drug Targets, Indications, Patents
An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib ...
Study Details | NCT07492641 | BGB-43395 Plus Letrozole ...
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of ...
First-in-human phase 1a, dose-escalation study of BGB- ...
Safety. • TEAEs occurred in 61/65 (93.8%) patients overall, and were primarily grades (gr) 1 and 2 (Table 2). • For all 65 patients, ...
BGB-43395 Alone or as Part of Combination Therapies in ...
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, ...
BGB-43395 / BeOne Medicines
A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395 ... safety that support further development in combination with letrozole.
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