Phenytoin or Itraconazole for Drug Absorption Study

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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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 it safe to use Phenytoin and Itraconazole together?

Phenytoin can significantly reduce the levels of Itraconazole in the body, which may affect its safety and effectiveness. Phenytoin has a narrow therapeutic index, meaning the difference between a safe dose and a harmful one is small, so careful monitoring is needed when using it. ^{1 2 3 4 5}

How does the drug BGB-16673 differ from other treatments?

BGB-16673 is studied alongside phenytoin and itraconazole to understand drug absorption, which is unique because phenytoin can significantly reduce itraconazole levels, affecting its effectiveness. This interaction highlights the importance of understanding how these drugs influence each other's absorption, which is not typically a focus in standard treatments. ^{2 3 6 7 8}

What data supports the effectiveness of the drug BGB-16673, Itraconazole, and Phenytoin?

The research indicates that phenytoin is a commonly used anticonvulsant drug, but its absorption can be affected by other substances, such as antacids and sucralfate, which may reduce its effectiveness. Additionally, phenytoin can significantly reduce the serum concentrations of itraconazole, suggesting potential interactions when these drugs are used together. ^{2 3 6 9 10}

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. England pubmed.ncbi.nlm.nih.gov

The effects of sucralfate upon phenytoin absorption in man. [2019]

2. Denmark pubmed.ncbi.nlm.nih.gov

In vivo absorption of phenytoin from rat small intestine and its inhibition by phlorizin. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Itraconazole and hydroxyitraconazole serum concentrations are reduced more than tenfold by phenytoin. [2017]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Bioavailability of phenytoin: clinical pharmacokinetic and therapeutic implications. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of antacids on phenytoin bioavailability. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Unusual absorption profile of phenytoin in a massive overdose case. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Is Bioequivalence Established Based on the Reference-Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin? Perspectives Based on Population Pharmacokinetic Modeling and Simulations. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Phenytoin prodrugs III: water-soluble prodrugs for oral and/or parenteral use. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Effect of cholestyramine and colestipol on the absorption of phenytoin. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Phenytoin I: in vitro-in vivo correlation for 100-mg phenytoin sodium capsules. [2019]