A Study of LY3473329 in Participants With Impaired and Normal Renal Function
- Registration Number
- NCT05778864
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3473329 (Control) LY3473329 LY3473329 administered orally to participants with normal renal function LY3473329 (Severe Renal Impairment) LY3473329 LY3473329 administered orally to participants with severe renal impairment LY3473329 (Mild Renal Impairment) LY3473329 LY3473329 administered orally to participants with mild renal impairment LY3473329 (Moderate Renal Impairment) LY3473329 LY3473329 administered orally to participants with moderate renal impairment LY3473329 (End-Stage Renal Disease) LY3473329 LY3473329 administered orally to participants with end-stage renal disease
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Alliance for Multispecialty Research, LLC
🇺🇸Knoxville, Tennessee, United States
Velocity Clinical Research, New Smyrna Beach
🇺🇸Edgewater, Florida, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States