Renal Insufficiency
Conditions
Brief summary
The main purpose of this study is to assess the amount of study drug (LY3473329) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3473329 will also be evaluated in these participants. The study will last up to 8 weeks including screening period.
Interventions
DRUGLY3473329
Administered orally.
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
* Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²) * Men who agree to use highly effective or effective methods of contraception, women of childbearing potential (WOCP) who agree to use highly effective or effective methods of contraception, and women not of childbearing potential (WNOCBP) may participate in this trial * Have clinical laboratory test results within the normal reference range for the population
Exclusion criteria
* Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study * Have any abnormality in the 12-lead electrocardiogram (ECG), blood pressure and/or pulse rate that, in the opinion of the investigator, increases the risks associated with participating in the study * Hemoglobin less than 8 grams/deciliter (g/dL) and/or clinically significant anemia symptoms * Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age * Smoke more than 10 cigarettes per day or the equivalent * Have donated blood of more than 500 milliliter (mL) within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329 | Predose up to 34 days postdose | PK: AUC0-∞ of LY3473329 |
| PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329 | Predose up to 34 days postdose | PK: AUC0-tlast of LY3473329 |
| PK: Maximum observed concentration (Cmax) of LY3473329 | Predose up to 34 days postdose | PK: Cmax of LY3473329 |
Countries
United States
Outcome results
None listed