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BGB-3111 and Drug Cocktail · 1 trial · 1 indication
AUC from time 0 to the last quantifiable concentration (AUC0-t)
| Arm | Type | Description |
|---|---|---|
| Single Arm: BGB-3111 + Drug Cocktail | EXPERIMENTAL | BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin) |
| Name | Type | Description |
|---|---|---|
| BGB-3111 and Drug Cocktail | DRUG | BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin) |
Inclusion Criteria: All Groups * Male subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening. * Subjects must have a body mass index (BMI) between 18 and 32 kg/m2. * Male subjects must agree to a highly effective metho...
BGB-3111, also known as zanubrutinib, is an investigational small molecule being studied for Waldenström's Macroglobulinemia, a rare type of non-Hodgkin lymphoma. It has also been evaluated in healthy volunteers for pharmacokinetic studies. The drug is currently in clinical development and is not yet approved for any indication.
BGB-3111 targets Bruton's tyrosine kinase (BTK), an enzyme involved in B-cell development and signaling. By inhibiting BTK, the drug aims to disrupt the growth and survival of malignant B-cells, which is relevant in Waldenström's Macroglobulinemia. This mechanism is being investigated in clinical trials.
BGB-3111 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Waldenström's Macroglobulinemia and in healthy subjects.
BGB-3111 is in Phase 1 clinical development. While a Phase 3 trial comparing BGB-3111 to ibrutinib in Waldenström's Macroglobulinemia has been completed, the drug remains investigational and has not received FDA approval. All trials listed for BGB-3111 are completed, with no active trials currently ongoing.
BGB-3111 has been studied in several completed clinical trials, including NCT03053440, a Phase 3 study comparing BGB-3111 to ibrutinib in 201 participants with Waldenström's Macroglobulinemia. Other trials include NCT03301181, NCT03432884, and NCT04163783, which were Phase 1 studies in healthy volunteers to assess drug interactions, cardiac effects, and metabolism.
Yes, BGB-3111 is also known as zanubrutinib. In clinical trials, the drug is referred to by both names, with zanubrutinib being the generic name used in study titles. This alternative name is important for identifying the drug in medical literature and regulatory documents.