Certara Limited Sheffield

What is the current knowledge on the topic? ○ Orally inhaled route of administration with direct drug delivery to the site of action is often considered for molecules intended to treat respiratory diseases. What question did this study address?

WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Brigatinib is an oral anaplastic lymphoma kinase (ALK) inhibitor approved for treatment of ALK-positive metastatic non-small cell lung cancer. Results of dedicated drug–drug interaction (DDI) studies indicated that co-administration of brigatinib with strong CYP3A inhibitors or inducers should be avoided. WHAT QUESTION DID THIS STUDY ADDRESS? Do moderate CYP3A inhibitors and inducers have clinically meaningful effects on brigatinib pharmacokinetics (PK)?

What is already known about this subject Clinical drug–drug interaction studies are difficult to conduct with long-acting drugs. It is unknown whether a dosing adjustment is required during the switch period from an efavirenz-containing regimen or other antiretrovirals with inducing properties to long-acting cabotegravir and rilpivirine. A physiologically based pharmacokinetic model can address this knowledge gap.