Investigating how phenytoin or itraconazole affects the absorption of BGB-16673 in healthy individuals
A Phase 1, Open-label, Fixed-sequence, Crossover Study to Investigate the Effect of Coadministration of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-16673 in Healthy Participants
This study is testing how the medications phenytoin or itraconazole affect the way healthy people absorb a new drug called BGB-16673.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | BeiGene Industry-sponsored |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06906809 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of coadministration of phenytoin or itraconazole on the pharmacokinetics of BGB-16673 in healthy participants. It involves administering BGB-16673 alongside either of the two drugs to assess how they influence the absorption and elimination of the investigational drug. The study is designed for healthy volunteers aged 18 to 65, ensuring they meet specific health criteria. The findings could provide insights into drug-drug interactions and inform future dosing strategies.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 65 with a body mass index between 18.0 and 32.0 kg/m2.
Not a fit: Patients with significant medical histories or ongoing health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of drug interactions, leading to safer and more effective medication regimens.
How similar studies have performed: While drug-drug interaction studies are common, the specific combination of BGB-16673 with phenytoin or itraconazole is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, of any race, between 18 and 65 years of age * In good health, as determined by no clinically significant findings from medical history,12- lead ECG and vital signs measurements, physical examination and clinical laboratory evaluations * Body mass index between 18.0 and 32.0kg/m2, inclusive Exclusion Criteria: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee. * Evidence of any infections (bacterial, viral, fungal, parasitic) within 4 weeks prior to the first dose of study drug, as determined by the investigator (or designee). * History of malignancy, except for appropriately treated carcinoma in situ of the cervix or nonmelanoma skin carcinoma not requiring ongoing systemic treatment. * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed). * Participants who have acute gastrointestinal symptoms at the time of screening and or/admission (eg, nausea, vomiting, diarrhea, or heartburn).
Where this trial is running
Madison, Wisconsin
- Fortrea Clinical Research Unit Inc — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: clinicaltrials@beigene.com
- Phone: 1-877-828-5568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.