An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment
An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Panel A: Participants with Severe Renal Impairment:
- History of any illness, other than hypercholesterolemia and Renal Impairment
Panel B: Healthy Participants:
- History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases, other than hypercholesterolemia