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

Phase 1

Completed

• Conditions: Renal Impairment; Disease Severity
• Interventions: Drug: Lenvatinib

• Registration Number: NCT02199379
• Lead Sponsor: Eisai Inc.

Brief 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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-24
• Status Verified: 2015-01
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lenvatinib	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of lenvatinib: Cmax	Day 1 to Day 8
Pharmacokinetics of lenvatinib: AUC(0-t)	Day 1 to Day 8
Pharmacokinetics of lenvatinib: AUC(0-inf)	Day 1 to Day 8

Secondary Outcome Measures

Name	Time	Method
Safety as Measured by Outcome of serious adverse events (SAEs)	Screening, Baseline and Treatment period (Day 1 to Day 8)
Safety as Measured by performance of physical examinations.	Screening, Baseline and Treatment period (Day 1 to Day 8)
Safety as Measured by ECGs	Screening, Baseline and Treatment period (Day 1 to Day 8)
Safety as Measured by Laboratory Values	Screening, Baseline and Treatment period (Day 1 to Day 8)
Safety as Measured by vital signs	Screening, Baseline and Treatment period (Day 1 to Day 8)
Safety as Measured by Outcome of all Adverse Events (AEs)	Screening, Baseline and Treatment period (Day 1 to Day 8)
Safety as Measured by Outcome of treatment-emergent AEs (TEAEs)	Screening, Baseline and Treatment period (Day 1 to Day 8)