Hepatic Impairment; Renal Impairment Clinical Trial
Official title:
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
Verified date | September 2018 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | July 8, 2017 |
Est. primary completion date | July 8, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | New Orleans Center for Clinical Research | Knoxville | Tennessee |
United States | DaVita Clinical Research | Minneapolis | Minnesota |
United States | Orlando Clinical Research Center, Inc. | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with any serious adverse event and any non-serious adverse event | 1 week |