for the fed group was ~ 6% greater than that of the fasted group. Cmax for the fed group was variable and 4.5% lower than that of the fasted group. The study was unpowered, the 90% CIs for AUC0-∞ and were within the 80-125% CI BE range. Drug interaction, E7080-A001-004 * healthy volunteers A single centre, randomised, crossover PK in healthy volunteers to assess the influence of simultaneous CYP3A4 and P-gp inhibition on lenvatinib PK following single dose oral 5 mg ketoconazole increases AUC (15-19%) but no change in t1/2, Tmax E7080-A001-007 * A single centre, sequential design, PK study to assess the influence of CYP3A4 induction with multiple doses of rifampin, unbound lenvatinib exposure was reduced about 9% and about 18% for total lenvatinib. PK in Target population special (cancer) population Multi dose * * E7080-J081-103 E7080-J081-105 * E7080-E044-104 * Mass balance study of 14C Lenvatinib Lung cancer I dose escalation study of lenvatinib with carboplatin and paclitaxel in Stage IIIB or IV non small cell lung cancer after multiple doses of lenvatinib; PK
for the fed group was ~ 6% greater than that of the fasted group. Cmax for the fed group was variable and 4.5% lower than that of the fasted group. The study was unpowered, the 90% CIs for AUC0-∞ and were within the 80-125% CI BE range. Drug interaction, healthy volunteers E7080-A001-004 A single centre, randomised, crossover PK in healthy volunteers to assess the influence of simultaneous CYP3A4 and P-gp inhibition on lenvatinib PK following single dose oral 5 mg ketoconazole increases AUC (15-19%) but no change in t1/2, Tmax * E7080-A001-007 A single centre, sequential design, PK study to assess the influence of CYP3A4 induction with multiple doses of rifampin, unbound lenvatinib exposure was reduced about 9% and about 18% for total lenvatinib. * PK in special population Target population (cancer) Multi dose * * E7080-J081-103 E7080-J081-105 * E7080-E044-104 Mass balance study of 14C Lenvatinib * Lung cancer I dose escalation study of lenvatinib with carboplatin and paclitaxel in Stage IIIB or IV non small cell lung cancer after multiple doses of lenvatinib; PK