Healthy Volunteers Clinical Trial
The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and P-glycoprotein induction on lenvatinib pharmacokinetics following single dose oral administration of 24 mg lenvatinib to healthy volunteers.
This is a single-dose, open-label, sequential, three-period study in 15 healthy subjects to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and P-glycoprotein induction on lenvantinib pharmacokinetics following single dose oral administration of 24 mg lenvatinib to healthy volunteers. The study will consist of two phases: Pretreatment and Treatment. The Pretreatment Phase will have two periods: Screening and Baseline 1. The purpose of the Screening Period is to obtain informed consent and to establish protocol eligibility. The purpose of the Baseline 1 is to confirm protocol eligibility. The Treatment Phase will have three periods: Treatment Period 1, Treatment Period 2, and Treatment Period 3 with a Baseline 2 assessment prior to Treatment Period 2 and a Baseline 3 assessment prior to Treatment Period 3. The purpose of Baselines 2 and 3 are to confirm continued protocol eligibility. In the Treatment Phase, subjects will take a single oral dose of 24 mg lenvatinib on three separate occasions (Period 1, Day 1; Period 2, Day 15; and Period 3, Day 43). In Period 2, Day 15, subjects will also take a single oral dose of 600 mg po rifampin. In Period 3, subjects will receive 600 mg rifampin po daily for 21 days (Period 3, Days 29 to 49). On Day 43 of Period 3, subjects will take 24 mg lenvatinib in addition to the rifampin. ;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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