Phenytoin or Itraconazole for Drug Absorption Study

No longer recruiting at 1 trial location

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Disqualifiers: Metabolic, Cardiovascular, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 36 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two drugs, phenytoin and itraconazole, affect the absorption of a new treatment called BGB-16673. The researchers aim to understand how the body processes BGB-16673 when taken with either of these drugs. Participants will be divided into groups to test each drug's impact on BGB-16673. This trial is for healthy individuals without ongoing health conditions or stomach issues like nausea or heartburn. As a Phase 1 trial, the research focuses on understanding how BGB-16673 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 drug absorption, it's possible that some medications might need to be paused. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the safety of BGB-16673, when combined with phenytoin or itraconazole, remains under investigation. In some studies, participants experienced health changes, including unusual lab results, which can occur during or after the study.

Phenytoin can alter how other drugs function in the body, prompting its study with BGB-16673. Itraconazole, used to treat fungal infections, can also influence how drugs enter the bloodstream. Both medicines are already approved for other uses, indicating general safety, but their effects with BGB-16673 are still being researched.

As this study is in the early stages, it primarily focuses on understanding how BGB-16673 interacts with these two drugs. This phase aims to gather basic safety information, requiring more data to confirm how well BGB-16673 is tolerated when taken with phenytoin or itraconazole. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BGB-16673 because it is being studied for its interaction with other drugs, which could potentially enhance drug absorption in the body. This investigational treatment is unique because it is being tested alongside Phenytoin, a CYP3A inducer, and Itraconazole, a CYP3A inhibitor, to understand how it is metabolized when combined with these agents. By exploring these interactions, researchers hope to optimize the effectiveness and safety of BGB-16673, potentially offering a new approach to managing drug absorption compared to existing options.

What evidence suggests that this trial's treatments could be effective?

Research has shown that BGB-16673 is primarily being studied for treating B-cell malignancies, a type of blood cancer. This drug targets cancer cells specifically, although detailed information from human studies remains limited. In this trial, participants will be divided into different arms to study drug interactions. One arm will receive BGB-16673 with Itraconazole, an antifungal medication that has shown potential to slow cancer cell growth in certain cancers. Another arm will receive BGB-16673 with Phenytoin, typically used to control seizures. In this study, researchers are testing Phenytoin to see how it affects the absorption and elimination of BGB-16673. While specific data on the effectiveness of BGB-16673 with Phenytoin or Itraconazole is not yet available, the studies aim to understand these drug combinations by examining their processing in the body. ^{2 6 7 8 9}

Who Is on the Research Team?

Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

This trial is for healthy men and women, aged 18-65, with a BMI between 18.0 and 32.0 kg/m2. Participants should have no significant medical issues based on their history, physical exams, ECGs (heart tests), or lab results.

Inclusion Criteria

Body mass index between 18.0 and 32.0kg/m2, inclusive

I am in good health with no significant medical issues.

Exclusion Criteria

I don't have major health issues in areas like the liver, kidneys, heart, or lungs.

I have not had any infections in the last 4 weeks.

I have had cancer before, but it was either cervical cancer treated without spreading or a skin cancer that didn't need ongoing treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of Phenytoin or Itraconazole to determine their effect on BGB-16673

Up to approximately 36 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BGB-16673
• Itraconazole
• Phenytoin

Trial Overview The study is looking at how the body absorbs and processes BGB-16673 when taken with either Phenytoin or Itraconazole. These are common medications; Phenytoin is used for seizures and Itraconazole for fungal infections.

How Is the Trial Designed?

Group I: Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor) Experimental Treatment 2 Interventions

Participants will receive multiple doses of Itraconazole to determine its effect on BGB-16673

Group II: Part A: BGB-16673 + Phenytoin (CYP3A Inducer) Experimental Treatment 2 Interventions

Participants will receive multiple doses of Phenytoin to determine its effect on BGB-16673

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/edfa9eddf00a4a45/nct06906809-phenytoin-itraconazole-bgb16673-pharmacokinetics

Effect of Phenytoin or Itraconazole on How BGB-16673 is ... The purpose of this study is to investigate the effect of coadministration of phenytoin or itraconazole on the pharmacokinetics of BGB-16673 in healthy ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06906809/effect-of-phenytoin-or-itraconazole-on-how-bgb-16673-is-absorbed-and-removed-from-the-body-in-healthy-participants

Effect of Phenytoin or Itraconazole on How BGB-16673 is ... The purpose of this study is to investigate the effect of coadministration of phenytoin or itraconazole on the pharmacokinetics of BGB-16673 ...

3. clinicaltrials.eu clinicaltrials.eu/inn/bgb-16673/

BGB-16673 – Application in Therapy and Current Clinical ... BGB-16673 is an innovative drug currently being studied in clinical trials for various conditions, primarily B-cell malignancies such as chronic lymphocytic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10520254/

Efficacy of Super-Bioavailable Itraconazole and Conventional ... In this clinical study, moderate efficacy with all doses of ITZ was reported but was better with OD dosing. Although there was no statistical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04018872

NCT04018872 | Evaluating the Effect of Itraconazole on ... Itraconazole, a widely used anti-fungal medication, has been shown to inhibit various pathways involved in esophageal cancer tumorigenesis including Hh and AKT.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06906809

Effect of Phenytoin or Itraconazole on How BGB-16673 is ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-3-2025-fecc9

Phenytoin or Itraconazole for Drug Absorption Study BGB-16673 is studied alongside phenytoin and itraconazole to understand drug absorption, which is unique because phenytoin can significantly reduce itraconazole ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38667795/

A Drug-Drug Interaction Study Pharmacokinetics and Safety of Lurbinectedin Administrated with Itraconazole in Cancer Patients: A Drug-Drug Interaction Study. Mar Drugs.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06906809?aggFilters=status:rec,ages:older&country=United%20States&state=Wisconsin&city=Madison&locStr=Madison,%20Wisconsin,%20United%20States&lastUpdPost=2019-06-28_&viewType=Table&rank=10

Effect of Phenytoin or Itraconazole on How BGB-16673 is ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...