Healthy, Hepatic Insufficiency
Conditions
Keywords
Pharmacokinetics, Hepatic Impairment
Brief summary
The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the screening period.
Interventions
DRUGLY3437943
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
All Participants: * Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive * Healthy or various degrees of hepatic impairment depending on the study group
Exclusion criteria
Participants with hepatic impairment: * Have or are anticipating an organ transplant within the next 6 months * Requires needle evacuation of ascites fluid more than 2 times per month * Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943 | Predose up to 30 days postdose | PK: AUC0-∞ of LY3437943 |
| PK: Maximum observed concentration (Cmax) of LY3437943 | Predose up to 30 days postdose | PK: Cmax of LY3437943 |
Countries
United States
Outcome results
None listed