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

• Status: Completed
• Trial end date: 2017-07-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Lenvatinib

Criteria

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 Exclusion Criteria:

• Use of any new medication

• Human immunodeficiency virus (HIV) positive

• Presence of acute active liver disease or acute liver injury

• History of significant cardiovascular impairment

• Positive drug or alcohol test

• Weight loss or gain of >10% prior to Day 1

• Receipt of blood or blood products or donation of blood or blood products

For participants with hepatic impairment:

• History of hepatic transplant, systemic lupus erythematosus, or hepatic coma

• Received treatment with interferon or pegylated interferon

• Participants who have encephalopathy >Grade 2, sepsis, or gastrointestinal bleeding; esophageal varices >Grade 2, acute hepatic failure of any etiology, history of surgical portosystemic shunt, renal impairment (creatinine clearance <50 mL/min according to the Cockcroft-Gault formula), and rapidly deteriorating hepatic function

• Systolic blood pressure (SBP) ≥ 160 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) ≥ 100 mmHg

For healthy participants:

• Hemoglobin level less than 12.0 grams per deciliter (g/dL)

For participants with renal impairment:

• A history of renal transplant

• SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg for participants with mild renal impairment; SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg for participants with moderate and severe renal impairment

• Significant bleeding diathesis