NCT02421042

A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh system, who will be matched with normal healthy subjects as controls.

Detailed description

This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh system, who will be matched with normal healthy subjects as controls. The study will be conducted in two phases: Pretreatment and Treatment. The Pretreatment Phase will have two periods: Screening and Baseline. The study will enroll a sufficient number of subjects so that at least 24 subjects complete the study. This will include six subjects with mild hepatic impairment (Group 1), six subjects with moderate hepatic impairment (Group 2), four to six subjects with severe hepatic impairment (Group 3), and eight subjects with normal hepatic function (Group 4). Potential study subjects with hepatic impairment (Groups 1, 2, and 3) and those with normal hepatic function (Group 4) will first be screened for study entry. Group 1, 2, and 3 subjects will be enrolled sequentially into the study first. The Group 4 normal healthy subjects will be enrolled following enrollment of all of the hepatic impairment subjects. Subjects determined to be eligible for the protocol will receive either a 5- or 10-mg single oral dose of lenvatinib on Day 1, depending on their hepatic status. Subjects will be discharged from the unit on Day 17 (+/- 2 days) after all study discharge procedures have been completed.

Conditions

• Hepatic Impairment
• Hepatic Function

Interventions

Type	Name	Description
DRUG	Lenvatinib	5- or 10-mg single oral dose of E7080, depending on their hepatic status \[Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)\].

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2015-04-20
• Last updated: 2015-05-05

Locations

5 sites across 1 country: United States