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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency
• Intervention / Treatment: Drug: LY3473329

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Edgewater, Florida, United States, 32132
      • Velocity Clinical Research, New Smyrna Beach
    • Miami, Florida, United States, 33417
      • Advanced Pharma CR, LLC
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Actual): September 6, 2024
• Study Completion (Actual): September 6, 2024

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency
• Other Study ID Numbers: 18638; J2O-MC-EKBE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No