24 Participants NeededMy employer runs this trial

BGB-43395 for Drug Interaction Study

Recruiting at 1 trial location
SD
Overseen ByStudy Director
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: BeOne Medicines
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research has shown that BGB-43395 is generally safe. In earlier studies, about 94% of participants experienced side effects, but most were mild to moderate. This indicates the treatment is safe for most people. Severe reactions were not commonly reported, supporting its overall safety.12345

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?

SD

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

I am in good health based on recent medical tests and exams.
My body mass index is between 18 and 32.
I am not pregnant or breastfeeding and agree to use contraception.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment Part 1

Participants receive midazolam and celecoxib alone and with BGB-43395

3 weeks
Multiple visits for drug administration and monitoring

Treatment Part 2

Participants receive dabigatran and rosuvastatin alone and with BGB-43395

3 weeks
Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

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

Group I: Part 2Experimental Treatment3 Interventions
Group II: Part 1Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

BeOne Medicines

Lead Sponsor

Fortrea

Industry Sponsor

Trials
22
Recruited
5,800+

Citations

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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 ...

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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.