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

Completed · Early Phase 1

Conditions studied: Hepatic Impairment; Renal Impairment

In brief

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.

Key facts

Study ID

NCT02998775

Run by

Eisai Inc.

People needed

54

Starts

2016-12-02

Expected to finish

2017-07-08

Last updated by the study team

2018-09-07

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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