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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
54
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
Orlando Clinical Research Center, Inc.
Orlando, Florida, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Number of participants with any serious adverse event and any non-serious adverse event
Time frame: 1 week
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