Hepatic Impairment; Renal Impairment
Conditions
Keywords
in vitro protein binding, hepatic impairment, renal impairment
Brief 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.
Interventions
DRUGPlasma Sampling
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
Sponsors
Eisai Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Male or Female * Age, at the time of Informed Consent: i. Hepatic Impairment Participants (Including Matched Healthy Participants): 18 to 70 years old, inclusive ii. Renal Impairment Participants (Including Matched Healthy Participants): 18 to 79 years old, inclusive * Non-smokers and smokers who smoke no more than 10 cigarettes per day * Besides diabetes and, as appropriate, renal or hepatic impairment, participants must have no history of acute or chronic clinically relevant disease or condition, as determined by the investigator. * For participants with hepatic impairment: * Liver cirrhosis that has been stable; * Platelet count \>30,000 cells/millimeter cubed (mm\^3); * Total score on the Child-Pugh classification system between 5 and 6 (Group 1, mild), 7 and 9 (Group 2, moderate), and 10 and 15 (Group 3, severe) * For healthy participants: • Creatinine clearance ≥ 81 milliliter per minute (mL/min) * For participants with renal impairment: * Must have a diagnosis of renal impairment that has been stable * Must have renal impairment in the following categories based on creatinine clearance values: mild (creatinine clearance, 50 to 80 mL/min), moderate (creatinine clearance, 30 to 49 mL/min), or severe (creatinine clearance, 15 to 29 mL/min) renal impairment
Exclusion criteria
Key
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with any serious adverse event and any non-serious adverse event | 1 week |
Countries
United States
Outcome results
None listed