NCT02998775

Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding

A Multicenter Phase 0 Study In Healthy Subjects and Subjects With Either Hepatic Or Renal Impairment To Obtain Plasma For Assessment In Vitro Lenvatinib Protein Binding

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. The primary objective of the study is to obtain plasma from participants for use in in vitro protein binding studies.

Detailed description

E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. Approximately 6 participants with each degree (mild, moderate, or severe) of hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be enrolled. One cohort of healthy participants will be matched to the hepatic-impaired participants, whereas the other will be matched to the renal-impaired participants. The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered in this study. The end of the study will be the date of the last study visit for the last participant in the study. The following estimates are provided: * From first participant in to last participant out, the study is expected to take approximately one year to complete. * The maximum estimated duration of the study for each participant is anticipated to be approximately 5 weeks.

Conditions

• Hepatic Impairment; Renal Impairment

Interventions

Type	Name	Description
DRUG	Plasma Sampling	No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.

Timeline

• Start date: 2016-12-02
• Primary completion: 2017-07-08
• Completion: 2017-07-08
• First posted: 2016-12-20
• Last updated: 2018-09-07

Locations

3 sites across 1 country: United States