NCT02199379

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Impairment
• Disease Severity

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib will be taken as a single dose of 24 mg consisting of 2 x 10 mg and 1 x 4 mg capsules. Treatment will be administered orally with 240 mL of water following a 10-hour overnight fast.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2014-07-24
• Last updated: 2015-04-14

Locations

3 sites across 1 country: United States