A Study of LY3473329 in Participants With Impaired and Normal Renal Function

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics of LY3473329 Following Oral Administration in Participants With Renal Impairment Compared With Participants With Normal Renal Function

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Drug: LY3473329


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3473329 (Control)<br>LY3473329 administered orally to participants with normal renal function | Drug: LY3473329<br>* Administered orally.<br>|
| Experimental: LY3473329 (Mild Renal Impairment)<br>LY3473329 administered orally to participants with mild renal impairment | Drug: LY3473329<br>* Administered orally.<br>|
| Experimental: LY3473329 (Moderate Renal Impairment)<br>LY3473329 administered orally to participants with moderate renal impairment | Drug: LY3473329<br>* Administered orally.<br>|
| Experimental: LY3473329 (Severe Renal Impairment)<br>LY3473329 administered orally to participants with severe renal impairment | Drug: LY3473329<br>* Administered orally.<br>|
| Experimental: LY3473329 (End-Stage Renal Disease)<br>LY3473329 administered orally to participants with end-stage renal disease | Drug: LY3473329<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329 | PK: AUC0-∞ of LY3473329 | Predose up to 34 days postdose | 
| PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329 | PK: AUC0-tlast of LY3473329 | Predose up to 34 days postdose | 
| PK: Maximum observed concentration (Cmax) of LY3473329 | PK: Cmax of LY3473329 | Predose up to 34 days postdose |