Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Pro… (NCT02998775) | Clinical Trial Compass
CompletedEarly Phase 1
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
United States54 participantsStarted 2016-12-02
Plain-language 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.
Who can participate
Age range18 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of participants with any serious adverse event and any non-serious adverse event