Renal Impairment Clinical Trial
Official title:
A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects
The purpose of this multicenter, open-label, non-randomized, single, oral dose, sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg) administered to healthy subjects and to subjects with renal impairment.
This is a multicenter, open-label, non-randomized, single-dose, sequential-cohort trial in subjects with renal impairment and healthy subjects. The study consists of two phases: A Pretreatment Phase and a Treatment Phase. The two periods in the Pretreatment Phase are: (1) the Screening Period (lasting up to 29 days), and (2) the Baseline Period (one day). The Treatment Period of the Treatment Phase lasts 8 days. The study will enroll a sufficient number of subjects so that 24 to 26 subjects complete the study. This will include six subjects with mild renal impairment (Group 1), six subjects with moderate renal impairment (Group 2), four to six subjects with severe renal impairment (Group 3) and eight subjects with normal renal function (Group 4). Subjects determined to be eligible for the protocol will receive a single 24-mg oral dose of E7080 on Day 1. Subjects will be discharged from clinical site on Day 8. ;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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