The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild, moderate, or severe liver function impairment compared to participants with normal liver function. The study will also evaluate how well lepodisiran is tolerated and what side effects may occur in these participants. The study will last up to approximately 9 weeks, excluding screening.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
33
Lepodisiran administered SC
Clinical Pharmacology of Miami
Miami, Florida, United States
RECRUITINGOrlando Clinical Research Center
Orlando, Florida, United States
RECRUITINGAmerican Research Corporation at Texas Liver Institute
San Antonio, Texas, United States
RECRUITINGCRU Early Phase Unit
Kistarcsa, Hungary
RECRUITINGPharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran
PK: AUC of Lepodisiran
Time frame: Baseline Up to 9 weeks
PK: Maximum Concentration (Cmax) of Lepodisiran
PK: Cmax of Lepodisiran
Time frame: Baseline Up to 9 weeks
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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