BGB-43395 drug interaction study in healthy adults
Official title: A Phase 1, Open-label, Fixed-sequence Trial in Healthy Participants to Assess the Drug Interaction Potential of BGB-43395 With A Drug Cocktail Representative for CYP3A4, CYP2C9, P-gp, and BCRP Substrates
Run by BeOne Medicines · NCT07820891 · Data updated 2026-11-12
This study tests if the drug BGB-43395 changes how other medicines are processed in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | BeOne Medicines Industry-sponsored |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | September 25, 2026 |
| Main results expected | November 22, 2026 |
| Study ends | November 22, 2026 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07820891 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged typical adult range with BMI 18.0–32.0 kg/m2, in good health, not pregnant or lactating, and willing to use contraception.
✕Probably not a fit
Those with significant medical conditions or abnormal screening results may not benefit and may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 study in healthy adults to see whether BGB-43395 affects the way other drugs are metabolized. The trial has two parts: Part 1 tests interactions with midazolam and celecoxib, and Part 2 tests interactions with dabigatran and rosuvastatin. Approximately 24 participants will receive BGB-43395 alone and with the co-administered drugs, with blood sampling, vital signs, and ECG monitoring over up to 7 weeks. The goal is to determine if BGB-43395 alters the pharmacokinetics of the comparator drugs.
Why it matters
Potential benefit: Participants may not directly benefit, but the data could help determine safe dosing for future patients treated with BGB-43395.
How similar studies have gone: Drug interaction studies in healthy volunteers have been conducted for similar CDK4 inhibitors to characterize pharmacokinetic interactions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index between 18.0 and 32.0 kg/m\^2, inclusive. * In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram and vital signs measurements, and clinical laboratory assessments. * Participants must not be pregnant or lactating and must agree to use contraception. 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 * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs * Confirmed systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, or pulse rate \>100 or \<40 beats per minute. Note: Other protocol-defined inclusion and exclusion criteria may apply.
Where it's running
-
Fortrea Clinical Research Unit
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Study Director
- Email: clinicaltrials@beonemed.com
- Phone: 877-828-5568
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.